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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insulinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Stented EN

Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.

Group Type EXPERIMENTAL

placement of pancreatic duct stents before enucleation surgery

Intervention Type PROCEDURE

Advance placement of pancreatic stents endoscopically

Direct EN

Patients will receive enucleation surgery directly following normal procedure

Group Type ACTIVE_COMPARATOR

Direct enucleation surgery

Intervention Type PROCEDURE

Patients will receive direct enucleation surgery

Interventions

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placement of pancreatic duct stents before enucleation surgery

Advance placement of pancreatic stents endoscopically

Intervention Type PROCEDURE

Direct enucleation surgery

Patients will receive direct enucleation surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No