A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 399
- Locations
- 28
- Primary Endpoint
- 60-day ≥ Grade II Complication Rate
Study Overview
Brief Summary
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
Detailed Description
The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.
Hypothesis:
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.
Objectives:
Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subject has a surgical indication for distal pancreatectomy.
- •In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.
- •At least 18 years of age.
- •The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- •The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Exclusion Criteria
- •The subject does not have a surgical indication for distal pancreatectomy.
- •In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.
- •Less than 18 years of age.
- •The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- •The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Outcomes
Primary Outcomes
60-day ≥ Grade II Complication Rate
Time Frame: 60 days
The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.
Secondary Outcomes
- 90-day Mortality Rate(90 days)
- 60-day ≥ Grade III Complication Rate(60 days)
- Serious Adverse Event (SAE) Rate(60 days)
- Median Complication Severity Grade(60 days)
- 60-day Frequency of Complications(60 days)
- Length of Stay for the Index Admission(60 days)
- Rate of Specific Complications(60 days)
- Crude Cost(60 days)
- Composite Quality of Life Scores(30 days and 60 days)
Investigators
William E Fisher
Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery
Baylor College of Medicine