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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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Insulinoma

NCT05523778

Peking Union Medical College Hospital

28 January 2024

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