Actively Recruiting
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Led by Case Comprehensive Cancer Center · Updated on 2026-02-19
234
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
CONDITIONS
Official Title
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing a scheduled distal pancreatectomy, with or without concurrent splenectomy
- Age 18 years or older
- Able and willing to understand and sign a written informed consent document
You will not qualify if you...
- Under 18 years old
- Pregnant
- History of previous pancreatic surgery
- History of prior gastric resection, gastric bypass, or sleeve gastrectomy
- History of prior cystogastrostomy procedure
- Failed prior endoscopic intervention or ultrasound due to esophageal or gastrointestinal stricture
- Type 3 or Type 4 Paraesophageal Hernia seen on imaging or during surgery
- Undergoing concurrent resection of organs other than pancreas, spleen, or gallbladder
- Undergoing oversewing of the pancreatic transection margin
- Unexpected bleeding or adhesive disease during surgery making it unsafe to proceed without an intraabdominal drain
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
R
Robert Simon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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