Actively Recruiting
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
Led by Case Comprehensive Cancer Center · Updated on 2026-02-19
234
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether routine intraperitoneal drainage is necessary after distal pancreatectomy, a common surgery for tumors in the pancreas body or tail. This trial focuses on comparing outcomes related to postoperative complications including pancreatic fistula, readmission, and surgical site infections. It aims to determine if omitting drainage is not worse than using drainage when reinforced staple technology is applied. Participants will be randomly assigned to one of two groups: one receiving a 19 French Blake intraperitoneal drain placed near the pancreatic resection margin as the current standard of care, and the other not receiving any drain. The study monitors patients for complications and recovery following surgery to assess the safety and impact of omitting routine drainage. During the 90 days after surgery, researchers will track a composite of postoperative complications including pancreatic fistula grades, infections, and readmissions. Quality of life scores will be measured at 14 and 90 days postoperatively, along with hospital length of stay and healthcare costs. Participants will undergo regular assessments to monitor these outcomes and ensure safety throughout their recovery.
CONDITIONS
Brief Title
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- Age 18 years or older
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Patients under 18 years old
- Patients who are pregnant
- History of previous pancreatic surgery
- History of prior gastric resection, gastric bypass, or sleeve gastrectomy
- Prior cystogastrostomy procedure
- Failed prior endoscopic intervention or ultrasound due to gastrointestinal stricture
- Type 3 or Type 4 paraesophageal hernia on imaging or during surgery
- Undergoing concurrent resection of organs other than pancreas, spleen, or gallbladder
- Patients who undergo oversewing of the pancreatic transection margin
- Unexpected intraoperative bleeding or adhesive disease making it unsafe to proceed without a drain
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay up to 90 days postoperative
Participants undergo distal pancreatectomy surgery with or without placement of an intraperitoneal drain as per their assigned group. Immediate post-operative care follows the surgery.
Hospital stay with multiple assessments during first 90 days after surgery
Duration - Up to 90 days post surgery
Participants are followed for complications and recovery outcomes including quality of life and hospital readmissions up to 90 days after surgery.
Follow-up visits at day 14 and day 90 postoperative
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
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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