Clinical trial · Interventional
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
NCT05523778CI-TRIAL-00071010unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulinoma | Pancreatic Insulinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Direct enucleation surgery | Procedure | — | UNRESOLVED |
| placement of pancreatic duct stents before enucleation surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stented EN
- description
- Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
- interventionNames
- Procedure: placement of pancreatic duct stents before enucleation surgery
- type
- ACTIVE_COMPARATOR
- label
- Direct EN
- description
- Patients will receive enucleation surgery directly following normal procedure
- interventionNames
- Procedure: Direct enucleation surgery
Primary outcomes (1)
- measure
- Rate of POPF within 3 months after EN.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGao R, Yin B, Jin J, Tian X, Zhang Y, Wei J, Cao F, Wang Z, Ma Z, Wang M, Gou S, Cong L, Xu Q, Wu W, Zhao Y. Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres. BMJ Open. 2024 Apr 2;14(4):e078516. doi: 10.1136/bmjopen-2023-078516. PMID 38569703