Evaluating pancreatic duct stents before insulinoma surgery
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
This study is testing whether putting stents in the pancreatic duct before surgery helps people with insulinomas have better outcomes compared to just doing the surgery without stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05523778 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of placing pancreatic duct stents before enucleation surgery for insulinomas located near the main pancreatic duct versus performing direct enucleation without stenting. Patients with clearly diagnosed insulinomas will be randomly assigned to either the stented enucleation group or the direct enucleation group. The study will assess surgical outcomes, postoperative complications, and long-term prognosis, while also evaluating the economic implications of both approaches. Data will be collected through follow-up analyses to determine the feasibility and effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with a clear diagnosis of insulinoma located in the head and neck of the pancreas, with tumors ≤ 2mm from the main pancreatic duct.
Not a fit: Patients with larger tumors, severe cardiopulmonary complications, or those with invasive insulinomas may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications for patients with insulinomas.
How similar studies have performed: While similar studies have explored pancreatic interventions, this specific approach of preoperative stenting for insulinomas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Qiang Xu, Doctor
- Email: xuqiang@pumch.cn
- Phone: +86-13810096103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.