Clinical trial · Interventional
Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy
Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial
- 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)
Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Stump | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| reinforcement of the staple line | Procedure | — | UNRESOLVED |
| staple only | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Staple line plus reinforcement
- description
- In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.
- interventionNames
- Procedure: reinforcement of the staple line
- type
- OTHER
- label
- staple line with no reinforcement
- description
- In this control group, no additional reinforcement is used after transecting the pancreas with stapler.
- interventionNames
- Procedure: staple only
Primary outcomes (1)
- measure
- Clinically relevant postoperative pancreatic fistula (CR-POPF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant; * Aged from 18 - 80 years; * Preoperative diagnosis of serous or mucinous cystic adenoma; * Preoperative diagnosis of solid pseudopapillary tumor (SPT); * Preoperative diagnosis of neuroendocrine tumor; * Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN); * Preoperative diagnosis of or pseudocyst; * Preoperative diagnosis of distal pancreatic malignancies; * Patients willing to provide informed consent. Exclusion Criteria: * History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy); * Pancreatic trauma; * With pneumoperitoneum contraindications; * With severe heart or pulmonary diseases which is not fit for surgeries.
References
Publications (0)
Data not yet available