Pancreas Resection With and Without Drains

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441492
• Other study ID #: H-28324
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: July 25, 2017

Study information

• Verified date: August 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: July 25, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Tumor
• Pancreatitis

Intervention

Procedure:
• No Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
• Drains
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Florida Health	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University - Purdue University Indianapolis	Indianapolis	Indiana
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Winthrop-University Hospital	Mineola	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	60-day Frequency of Complications	This is the median number of complications per patients.	60 days
Secondary	90-day Mortality Rate		90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Elkins Pancreas Center