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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 30, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating insulinoma, which is a type of tumor in the pancreas that causes low blood sugar levels. The study aims to see if placing special tubes called pancreatic duct stents before the surgery to remove the tumor (a procedure known as enucleation) can improve the results and reduce costs compared to just going straight to surgery without the stents. Researchers want to find out if this method is safe and effective for patients.

To be eligible for the trial, participants must have a clear diagnosis of insulinoma that is single and located in the head and neck of the pancreas, specifically close to the main pancreatic duct. They should also have imaging results showing that the tumor is not larger than 2 millimeters away from the duct. Patients between the ages of 65 and 74 who are willing to voluntarily participate can join. If you take part in this study, you can expect to receive either the stent placement before surgery or just the surgery itself, and the team will monitor your health throughout the process. This trial is currently looking for participants, so it could be a good option for those who meet the criteria.

Gender

ALL

Eligibility criteria

• 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