Pancreas Resection With and Without Drains

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis; Pancreas Tumor
• Intervention / Treatment: Procedure: No Drains; Procedure: Drains

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.

Secondary:

A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida Health
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Purdue University Indianapolis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29424
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77338
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: No Drains; Patients who will not receive intraperitoneal drainage following pancreas resection.	Procedure: No Drains; A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
EXPERIMENTAL: Drains; Patients who will receive drains, the standard of care treatment, following pancreas resection.	Procedure: Drains; A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).; Other Names: The specific brand of drain is not contolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day ≥ Grade II Complication Rate	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.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day ≥ Grade III Complication Rate	This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.	60 days
Serious Adverse Event (SAE) Rate	This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.	60 days
Median Complication Severity Grade	This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced	60 days
60-day Frequency of Complications	This is the median number of complications per patients.	60 days
90-day Mortality Rate		90 days
Rate of Specific Complications	The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).	60 days
Length of Stay for the Index Admission	This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.	60 days
Crude Cost	This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.	60 days
Composite Quality of Life Scores	Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis. The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0~144. A lower score represents the worst quality of life.	30 days and 60 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: William E Fisher, MD, Baylor College of Medicine

Publications and helpful links

General Publications

• Van Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460.
• Fisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, Brunicardi FC. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011 Jul;13(7):503-10. doi: 10.1111/j.1477-2574.2011.00331.x.

Helpful Links

• Elkins Pancreas Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): July 25, 2017

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (ESTIMATE): September 27, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Distal pancreatectomy; Pancreas resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pancreatitis
• Other Study ID Numbers: H-28324