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Trial Title:
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
NCT ID:
NCT05523778
Condition:
Insulinoma
Conditions: Official terms:
Insulinoma
Conditions: Keywords:
Pancreatic enucleation
Pancreatic duct stent
Regular pancreatectomy
Health economics evaluation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
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
Intervention:
Intervention type:
Procedure
Intervention name:
placement of pancreatic duct stents before enucleation surgery
Description:
Advance placement of pancreatic stents endoscopically
Arm group label:
Stented EN
Intervention type:
Procedure
Intervention name:
Direct enucleation surgery
Description:
Patients will receive direct enucleation surgery
Arm group label:
Direct EN
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.
Detailed description:
The research contents of this study include: patients with insulinoma near the main
pancreatic duct in the head and neck of the pancreas were randomly divided into two
groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct
en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct
stent before surgery, and the next day or the next day after surgery, and the den group
received enucleation directly. The safety of the two groups was compared, including the
evaluation of surgical effect Postoperative complications and long-term prognosis based
on follow-up data analysis; At the same time, the differences between the two groups were
evaluated from the perspective of health economics.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Xu, Doctor
Phone:
+86-13810096103
Start date:
February 6, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Xuanwu Hospital, Beijing
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523778
