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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Insulinoma

Treatments: Procedure: placement of pancreatic duct stents before enucleation surgery; Procedure: Direct enucleation surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05523778

PANCSTENTEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Stented EN

Experimental group

Description:

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

Treatment:

Procedure: placement of pancreatic duct stents before enucleation surgery

Direct EN

Active Comparator group

Description:

Patients will receive enucleation surgery directly following normal procedure

Treatment:

Procedure: Direct enucleation surgery