Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number of participants with postoperative pancreatic fistula
Study Overview
Brief Summary
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.
Detailed Description
A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years
- •Elective distal pancreatectomy for primary pancreatic pathology
Exclusion Criteria
- •Informed consent not available
- •Emergency distal pancreatectomy
- •Presence of pancreatic duct stricture
- •Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
- •History of severe pancreatitis
Outcomes
Primary Outcomes
Number of participants with postoperative pancreatic fistula
Time Frame: Day 3 after operation
The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3
Secondary Outcomes
- Number of participants developing complications related to Endoscopic Retrograde Cholangiography(14 days after endoscopy)
- Number of participants developing post-operative morbidity(90 days)
- Number of participants developing post-operative mortality(90 days)
- Total length of hospital stay of participants(90 days after endoscopy and operation)
Investigators
Cheung Yue Sun
Clinical Associate Professor (honorary)
Chinese University of Hong Kong