A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct
1 other identifier
interventional
78
1 country
1
Brief Summary
The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 2, 2023
July 1, 2023
1.8 years
August 16, 2022
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of POPF within 3 months after EN.
Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)
3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion
Secondary Outcomes (10)
Rate of postoperative abdominal infection within 3 weeks after EN
3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
Rate of postoperative delayed gastric emptying within 3 weeks after EN
3 days to 3 weeks after enucleation (or the extubation time)
Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN
1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
Rate of postoperative dyspepsia within 6 months after EN
2 weeks to 6 months after enucleation,,up to 6 month after inclusion
Rate of postoperative lung infection within 3 weeks after EN
1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
- +5 more secondary outcomes
Study Arms (2)
Stented EN
EXPERIMENTALPatients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
Direct EN
ACTIVE COMPARATORPatients will receive enucleation surgery directly following normal procedure
Interventions
Advance placement of pancreatic stents endoscopically
Eligibility Criteria
You may qualify if:
- The clinical qualitative diagnosis of insulinoma was clear;
- The localization diagnosis was clear, and it was determined that the tumor was single, located in the head and neck;
- The distance between the tumor and the main pancreatic duct was determined to be ≤ 2mm by preoperative imaging (enhanced CT, MRI, etc.);
- Truly informed and voluntarily participate in this study.
You may not qualify if:
- Maximum diameter of the tumor \>2cm proved pathologically
- Severe cardiopulmonary complications before operation
- Combined with other known tumor diseases
- Insulinoma is invasive or has suspicious metastatic lesions
- Previous upper abdominal surgery history
- Refusal or inability to cooperate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Peking University First Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Ruijin Hospitalcollaborator
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
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. 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 centres. BMJ Open. 2024 Apr 2;14(4):e078516. doi: 10.1136/bmjopen-2023-078516.
PMID: 38569703DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors are kept blinded to participant group allocation. Objective clinical data are provided to independent assessors with blindness of allocation. With clear definition for each endpoints, assessors are able to make grading for complications in primary and secondary endpoints
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2022
First Posted
August 31, 2022
Study Start
February 6, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
November 2, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis."Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Data obtained through this study may be provided to qualified researchers with academic interest in the surgical treatment of insulinoma. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.