NCT05523778

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insulinoma

Interventions

Type	Name	Description
PROCEDURE	placement of pancreatic duct stents before enucleation surgery	Advance placement of pancreatic stents endoscopically
PROCEDURE	Direct enucleation surgery	Patients will receive direct enucleation surgery

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-08-31
• Last updated: 2023-11-02

Locations

1 site across 1 country: China