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Hoy — Mayo 14th 2024Tus fuentes RSS

Association between septic shock and tracheal injury score in intensive care unit patients with invasive ventilation: a prospective single-centre cohort study in China

Por: Zhang · P. · Yang · Q. · Yin · C. · Cai · Z. · Lu · H. · Li · H. · Li · L. · Tian · Y. · Bai · L. · Huang · L.
Objectives

There was no evidence regarding the relationship between septic shock and tracheal injury scores. Investigate whether septic shock was independently associated with tracheal injury scores in intensive care unit (ICU) patients with invasive ventilation.

Design

Prospective observational cohort study.

Setting

Our study was conducted in a Class III hospital in Hebei province, China.

Participants

Patients over 18 years of age admitted to the ICU between 31 May 2020 and 3 May 2022 with a tracheal tube and expected to be on the tube for more than 24 hours.

Primary and secondary outcome measures

Tracheal injuries were evaluated by examining hyperaemia, ischaemia, ulcers and tracheal perforation by fiberoptic bronchoscope. Depending on the number of lesions, the lesions were further classified as moderate, severe or confluent.

Results

Among the 97 selected participants, the average age was 56.6±16.5 years, with approximately 64.9% being men. The results of adjusted linear regression showed that septic shock was associated with tracheal injury scores (β: 2.99; 95% CI 0.70 to 5.29). Subgroup analysis revealed a stronger association with a duration of intubation ≥8 days (p=0.013).

Conclusion

Patients with septic shock exhibit significantly higher tracheal injury scores compared with those without septic shock, suggesting that septic shock may serve as an independent risk factor for tracheal injury.

Trial registration number

ChiCTR2000037842, registered 03 September 2020. Retrospectively registered, https://www.chictr.org.cn/edit.aspx?pid=57011&htm=4.

Exploring opportunities to strengthen rural tuberculosis health service delivery: a qualitative study with health workers in Tibet autonomous region, China

Por: Haldane · V. · Zhang · Z. · Yin · T. · Zhang · B. · Li · Y. · Pan · Q. · Dainty · K. N. · Rea · E. · Pasang · P. · Hu · J. · Wei · X.
Objectives

This qualitative study aimed to explore opportunities to strengthen tuberculosis (TB) health service delivery from the perspectives of health workers providing TB care in Shigatse prefecture of Tibet Autonomous Region, China.

Design

Qualitative research, semi-structured in-depth interviews.

Setting

The TB care ecosystem in Shigatse, including primary and community care.

Participants

Participants: 37 semi-structured interviews were conducted with village doctors (14), township doctors and nurses (14), county hospital doctors (7) and Shigatse Centre for Disease Control staff (2).

Results

The three main themes reported include (1) the importance of training primary and community health workers to identify people with symptoms of TB, ensure TB is diagnosed and link people with TB to further care; (2) the need to engage community health workers to ensure retention in care and adherence to TB medications; and (3) the opportunity for innovative technologies to support coordinated care, retention in care and adherence to medication in Shigatse.

Conclusions

The quality of TB care could be improved across the care cascade in Tibet and other high-burden, remote settings by strengthening primary care through ongoing training, greater support and inclusion of community health workers and by leveraging technology to create a circle of care. Future formative and implementation research should include the perspectives of health workers at all levels to improve care organisation and delivery.

Application of deep learning to pressure injury staging

Journal of Wound Care, Volume 33, Issue 5, Page 368-378, May 2024.
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Exploration of decision aids to support advance care planning: A scoping review

Abstract

Background

Advance care planning is a process through which people communicate their goals and preferences for future medical care. Due to the complexity of the decision-making process, decision aids can assist individuals in balancing potential benefits and risks of treatment options.

Objective

While decision aids have the potential to better promote advance care planning, their characteristics, content and application effectiveness are unclear and lack systematic review. Therefore, we aimed to explore these three aspects and establish a foundation for future research.

Design

Scoping review.

Methods

This scoping review adheres to the framework proposed by Arksey and O'Malley and the PRISMA-ScR list. Six English-language databases were systematically searched from the time of construction until 1 December 2023. Two researchers conducted the article screening and data extraction, and the extracted data was presented in written tables and narrative summaries.

Results

Of the 1479 titles and abstracts, 20 studies fulfilled the inclusion criteria. Types of decision aids were employed, mainly websites and videos. Decision aid's primary components center around 11 areas, such as furnishing information, exploring treatment and care preferences. The main manifestations were a significant increase in knowledge and improved recognition of patients' target value preferences. Among the aids, websites and videos for advance care planning have relatively high content acceptability and decision-making process satisfaction, but their feasibility has yet to be tested.

Conclusions

Decision aids were varied, with content focused on describing key information and exploring treatment and care preferences. Regarding application effects, the aids successfully facilitated the advance care planning process and improved the quality of participants' decisions. Overall, decision aids are efficient in improving the decision-making process for implementing advance care planning in cancer and geriatric populations. In the future, personalised decision aids should be developed based on continuous optimization of tools' quality and promoted for clinical application.

Reporting Method

The paper has adhered to the EQUATOR guidelines and referenced the PRISMAg-ScR checklist.

No Patient or Public Contribution

This is a review without patient and public contribution.

Registration: https://doi.org/10.17605/OSF.IO/YPHKF, Open Science DOI: 10.17605/OSF.IO/YPHKF.

The effect of home‐based exercise on motor and non‐motor symptoms with Parkinson's disease patients: A systematic review and network meta‐analysis

Abstract

Objective

To evaluate the effects of home-based exercise in Parkinson's disease (PD) patients.

Design

A network meta-analysis of randomized controlled trials.

Methods

This study systematically searched PubMed, MEDLINE, Embase, Cochrane library and Web of Science. The quality of the literature was assessed using the Cochrane Risk of Bias 2.0 criteria. The data were pooled using R software. Results are presented as pooled standardized mean difference (SMD) with 95% confidence interval (CI).

Results

Thirty studies involving 2264 PD patients were included. Meta-analysis results showed that home-based exercise had a small effect in relieving overall motor symptoms in PD patients (SMD: −.28, 95% Crl [−.43; −.14]), improving quality of life (SMD = .15 [.03, .26]), walking speed (SMD = .30 [.04, .56]), balance ability (SMD = .18 [.04, .33]; p < .0001) and finger dexterity (SMD = .28 [.10, .46]). Mixed exercise (Mix) had better effects on improving motor symptoms and quality of life. In addition, the results of dose analysis showed that only mixed exercise exceeding 850 METs-min per week and more than 18 weeks can significantly alleviate the overall motor symptoms of PD patients.

Conclusion

Home-based exercise was an effective form of therapy for alleviating motor symptoms. In addition, Mix appeared to be more suitable for PD patients engaging in home-based exercise. Existing evidence suggested that significant therapeutic effects were achieved with a Mix, with a weekly exercise volume exceeding 850 METs and a duration of more than 18 weeks.

Relevance to Clinical Practice

Home-based exercise had a small effect in relieving overall motor symptoms in PD patients, improving quality of life, walking speed, balance ability and finger dexterity. In terms of exercise dosage, we recommend the exercise period is no less than 18 weeks and the dose per is no less than 850 METs-min. No Patient or Public Contribution.

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L.
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

Meta‐analysis comparing different ultrasound detection methods to accurately assess wound healing and scar formation after caesarean section

Abstract

The accurate assessment of wound healing post-caesarean section, especially in twin pregnancies, remains a pivotal concern in obstetrics, given its implications for maternal health and recovery. Traditional methods, including conventional abdominal ultrasonography (CU), have been challenged by the advent of transvaginal ultrasonography (TU), offering potentially enhanced sensitivity and specificity. This meta-analysis directly compares the efficacy of TU and CU in evaluating wound healing and scar formation, crucial for optimizing postoperative care. Results indicate that TU is associated with significantly better outcomes in wound healing, demonstrated by lower REEDA scores (SMD = −20.56, 95% CI: [−27.34.20, −13.77], p < 0.01), and in scar formation reduction, evidenced by lower Manchester Scar Scale scores (SMD = −25.18, 95% CI: [−29.98, −20.39], p < 0.01). These findings underscore the potential of integrating TU into routine post-caesarean evaluation protocols to enhance care quality and patient recovery.

Wound healing rates in COPD patients undergoing traditional pulmonary rehabilitation versus tailored Wound‐Centric interventions

Por: Yan He · He Zhu · Wenjie Xu · Tao Wang · Ying Chen

Abstract

This comparative cross-sectional study, conducted at Shanghai Pulmonary Hospital, aimed to evaluate the efficacy of tailored wound-centric interventions (TWCI) versus traditional pulmonary rehabilitation (TPR) in enhancing wound healing in patients with chronic obstructive pulmonary disease (COPD). Enrolling 340 patients with confirmed COPD, the study randomly assigned participants to either the TWCI or TPR group for a 12-week programme. The primary outcome measured was the rate of wound healing, with secondary outcomes including changes in pulmonary function tests (PFTs) and quality of life (QoL) scores. The TWCI group received a customized programme integrating standard pulmonary rehabilitation with specific wound care strategies, such as enhanced oxygen therapy, nutritional supplementation, and infection control measures. In contrast, the TPR group underwent a conventional pulmonary rehabilitation programme without targeted wound care interventions. Wound healing rates, PFTs, and QoL scores were assessed at the end of the intervention and 3 months post-intervention. The TWCI group demonstrated a statistically significant improvement in wound healing rates compared with the TPR group. The TWCI group had a 15% higher rate of reduction in wound size, a 10% rise in complete healing rates, and a 20% drop in infection rates (p < 0.05). Specifically, TWCI group exhibited higher rates of wound size reduction, complete healing, and decreased infection rates. Additionally, long-term pulmonary function and overall quality of life improvements were more pronounced in the tailored group, underscoring the benefits of a personalized approach to managing COPD and wound care. The study concluded that integrating wound-specific care strategies with pulmonary rehabilitation significantly enhances health outcomes in COPD patients with wounds. These findings supported the adoption of customized, multidisciplinary care plans, suggesting that tailored interventions can offer a comprehensive solution to the complex needs of COPD patients, potentially redefining best practices in chronic disease management.

Status quo and influencing factors of multiprofessional and multidisciplinary teamwork for early mobilization in mechanically ventilated patients in ICUs: A multi‐centre survey study

Abstract

Aim

To understand the status quo of multiprofessional and multidisciplinary collaboration for early mobilization of mechanically ventilated patients in Chinese ICUs and identify any factors that may influence this practice.

Design

A multi-centre cross-sectional survey.

Methods

From October to November 2022, the convenience sampling method was used to select ICU multiprofessional and multidisciplinary early mobility members (including physicians, nurses and physiotherapists) from 27 tertiary general hospitals in 14 provinces, cities and autonomous regions of China. They were asked to complete an author-developed questionnaire on the status of collaboration and the Assessment of Inter-professional Team Collaboration Scale. A multiple linear regression model was used to analyse the factors associated with the level of collaboration.

Results

Physicians, nurses and physiotherapists mostly suffered from the lack of normative protocols, unclear division of responsibilities and unclear multiprofessional and multidisciplinary teams when using a collaborative approach to early activities. Multiple linear regression analysis showed that the number of ICU patients managed, the existence of norms and processes, the attitude of colleagues around them, the establishment of a team, communication methods and activity leaders were significant influences on the level of collaboration among members of the multiprofessional and multidisciplinary early activities.

Conclusion

The collaboration of multiprofessional and multidisciplinary early activity members for mechanically ventilated patients in the ICU remains unclear, and the collaboration strategy needs to be constructed and improved, taking into account China's human resources and each region's economic development level.

Impact

This study investigates the collaboration status of multiprofessional and multidisciplinary activity members from the perspective of teamwork, analyses the reasons affecting the level of collaboration and helps to develop better teamwork strategies to facilitate the implementation of early activities.

Patient or Public Contribution

The participants in this study were multiprofessional and multidisciplinary medical staff who performed early activities for ICU patients.

Predictors of fall protection motivation among older adults in rural communities in a middle‐income country: A cross‐sectional study using the Protection Motivation Theory

Abstract

Aims

To evaluate factors associated with fall protection motivation to engage in fall preventive behaviour among rural community-dwelling older adults aged 55 and above using the protection motivation theory scale.

Design

A cross-sectional study.

Methods

The study was conducted in a healthcare clinic in Malaysia, using multistage random sampling from November 2021 to January 2022. Three hundred seventy-five older adults aged 55 and older were included in the final analysis. There were 31 items in the final PMT scale. The analysis was performed within the whole population and grouped into ‘faller’ and ‘non-faller’, employing IBM SPSS version 26.0 for descriptive, independent t-test, chi-square, bivariate correlation and linear regressions.

Results

A total of 375 older participants were included in the study. Fallers (n = 82) and non-fallers (n = 293) show statistically significant differences in the characteristics of ethnicity, assistive device users, self-rating of intention and participation in previous fall prevention programmes. The multiple linear regression model revealed fear, coping appraisal and an interaction effect of fear with coping appraisal predicting fall protection motivation among older adults in rural communities.

Conclusion

Findings from this study demonstrated that coping appraisal and fear predict the protection motivation of older adults in rural communities. Older adults without a history of falls and attaining higher education had better responses in coping appraisal, contributing to a reduction in perceived rewards and improving protection motivation. Conversely, older adults from lower education backgrounds tend to have higher non-preventive behaviours, leading to a decline in fall protection motivation.

Implications for the profession and/or patient care

These results contribute important information to nurses working with older adults with inadequate health literacy in rural communities, especially when planning and designing fall prevention interventions. The findings would benefit all nurses, healthcare providers, researchers and academicians who provide care for older adults.

Patient or Public Contribution

Participants were briefed about the study, and their consent was obtained. They were only required to answer the questionnaire through interviews. Older individuals aged fifty-five and above in rural communities at the healthcare clinic who could read, write or understand Malay or English were included. Those who were suffering from mental health problems and refused to participate in the study were excluded from the study. Their personal information remained classified and not recorded in the database during the data entry or analysis.

Hyperbaric oxygen therapy promotes the browning of white fat and contributes to the healing of diabetic wounds

Abstract

Non-healing wounds are one of the chronic complications of diabetes and have remained a worldwide challenge as one of the major health problems. Hyperbaric oxygen (HBO) therapy is proven to be very successful for diabetic wound treatment, for which the molecular basis is not understood. Adipocytes regulate multiple aspects of repair and may be therapeutic for inflammatory diseases and defective wound healing associated with aging and diabetes. Endothelial cell-derived extracellular vesicles could promote wound healing in diabetes. To study the mechanism by which HBO promotes wound healing in diabetes, we investigated the effect of HBO on fat cells in diabetic mice. A diabetic wound mouse model was established and treated with HBO. Haematoxylin and eosin (H&E) staining and immunofluorescence were used for the analysis of wound healing. To further explore the mechanism, we performed whole-genome sequencing on extracellular vesicles (EVs). Furthermore, we conducted in vitro experiments. Specifically, exosomes were collected from human umbilical vein endothelial cell (HUVEC) cells after HBO treatment, and then these exosomes were co-incubated with adipose tissue. The wound healing rate in diabetic mice treated with HBO was significantly higher. HBO therapy promotes the proliferation of adipose precursor cells. HUVEC-derived exosomes treated with HBO significantly promoted fat cell browning. These data clarify that HBO therapy may promote vascular endothelial cell proliferation and migration, and promote browning of fat cells through vascular endothelial cells derived exosomes, thereby promoting diabetic wound healing. This provides new ideas for the application of HBO therapy in the treatment of diabetic trauma.

Factors associated with health behaviours among stroke survivors: A mixed‐methods study using COM‐B model

Abstract

Aims

To identify factors associated with health behaviours among stroke survivors, through a multi-centre study.

Design

A sequential mixed methods design.

Methods

In the quantitative research phase, a total of 350 participants were recruited through multi-stage sampling from December 2022 to June 2023. General information questionnaires, The Stroke Prevention Knowledge Questionnaire (SPKQ), Short Form Health Belief Model Scale (SF-HBMS), Health Promoting Lifestyle Profile (HPLPII), and the WHOQOL-BREF (World Health Organization Quality of Life Questionnaire, Brief Version) were distributed across five tertiary hospitals in Henan province, China. For the qualitative research component, semi-structured interviews were conducted to explore the barriers and facilitators of health behaviour. This study adheres to the GRAMMS guidelines.

Results

A total of 315 participants (90.0%) completed the survey. Identified barriers to health behaviour included residing in rural areas, higher scores on the Charlson Comorbidity Index (CCI) and mRS, as well as lower scores on SPKQ, SF-HBMS and WHOQOL-BREF. Twenty-four individuals participated in qualitative interviews. Twenty-eight themes were identified and categorised by frequency, covering areas such as knowledge, skills, intentions, social influences, social/professional role and identity, environmental context and resources, beliefs about capabilities, beliefs about consequences and behavioural regulation. Both quantitative and qualitative data suggested that health behaviour among stroke survivors is at a moderate level, and the identified barrier factors can be mapped into the COM-B model (Capability, Opportunity, Motivation and Behaviour).

Conclusion

The study indicates that key barriers to health behaviour among stroke survivors align with the COM-B model. These identified factors should be carefully considered in the planning of future systematic interventions aimed at improving health behaviours among stroke survivors.

Patient or Public Contribution

Patients were invited to completed questionnaires in the study and semi-structured interviews. The investigators provided explanation of this study’ content, purpose and addressed issues during the data collection.

Comprehensive analysis of risk factors for postoperative wound infection following radical mastectomy in breast cancer patients

Abstract

Surgical site infections (SSIs) following radical mastectomy in breast cancer patients can significantly affect patient recovery and healthcare resources. Identifying and understanding the risk factors for postoperative wound infections (PWIs) are crucial for improving surgical outcomes. This retrospective study was conducted from June 2020 to June 2023, including 23 breast cancer patients who developed PWIs post-radical mastectomy and a control group of 46 patients without such infections. Comprehensive patient data, including variables such as intraoperative blood loss, hospital stay duration, body mass index (BMI), operation time, anaemia, drainage time, diabetes mellitus, cancer stage, white blood cell (WBC) count, serum albumin levels and preoperative neoadjuvant chemotherapy, were meticulously gathered. Statistical analyses, including univariate and multivariate logistic regression, were performed using SPSS software (Version 27.0). The univariate analysis identified several factors significantly associated with an increased risk of PWIs, including preoperative neoadjuvant chemotherapy, low serum albumin levels, advanced cancer stage, diabetes mellitus and reduced WBC count. Multivariate logistic regression highlighted anaemia, prolonged drainage time, diabetes mellitus, advanced cancer stage, reduced WBC count, hypoalbuminemia and preoperative neoadjuvant chemotherapy as significant contributors to the increased risk of PWIs. Anaemia, extended drainage time, diabetes mellitus, advanced cancer stage, low WBC count, hypoalbuminemia and preoperative neoadjuvant chemotherapy are key risk factors for SSIs post-radical mastectomy. Early identification and proactive management of these factors are imperative to reduce the incidence of postoperative infections and enhance recovery outcomes in breast cancer patients.

Identification of IGF2 promotes skin wound healing by co‐expression analysis

Abstract

Oral mucosa is an ideal model for studying scarless wound healing. Researchers have shown that the key factors which promote scarless wound healing already exist in basal state of oral mucosa. Thus, to identify the other potential factors in basal state of oral mucosa will benefit to skin wound healing. In this study, we identified eight gene modules enriched in wound healing stages of human skin and oral mucosa through co-expression analysis, among which the module M8 was only module enriched in basal state of oral mucosa, indicating that the genes in module M8 may have key factors mediating scarless wound healing. Through bioinformatic analysis of genes in module M8, we found IGF2 may be the key factor mediating scarless wound healing of oral mucosa. Then, we purified IGF2 protein by prokaryotic expression, and we found that IGF2 could promote the proliferation and migration of HaCaT cells. Moreover, IGF2 promoted wound re-epithelialization and accelerated wound healing in a full-thickness skin wound model. Our findings identified IGF2 as a factor to promote skin wound healing which provide a potential target for wound healing therapy in clinic.

Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical cent

Por: Gao · R. · Yin · B. · Jin · J. · Tian · X. · Zhang · Y. · Wei · J. · Cao · F. · Wang · Z. · Ma · Z. · Wang · M. · Gou · S. · Cong · L. · Xu · Q. · Wu · W. · Zhao · Y.
Introduction

The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.

Methods and analysis

This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the X2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.

Ethics and dissemination

The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.

Trial registration number

NCT05523778.

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