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: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Qiang Xu, Doctor
xuqiang@pumch.cn
+86-13810096103
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 78
Treatments
Experimental: Stented EN
Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
Active_comparator: Direct EN
Patients will receive enucleation surgery directly following normal procedure
Related Therapeutic Areas
Sponsors
Collaborators: Ruijin Hospital, Xuanwu Hospital, Beijing, First Affiliated Hospital Xi'an Jiaotong University, Peking University First Hospital
Leads: Peking Union Medical College Hospital