Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy

A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Device: Jackson-Pratt Drain; Device: Non-suctioning drainage

Detailed Description

The most common complication following distal pancreatectomy is the developement of leakage from the remaining pancreas gland, which results in significant morbidity. Most surgeons leave dains at the time of surgery to prevent complications from pancreatic leakage. However, we hypothesize that drains which create continous negative pressure may contribute to the development of a pancreatic fistula. This study randomizes patients to suctioning versus non-suctioning drains. The primary endpoint is the development of pancreatic fistuale, as defined by the International Study Group of Pancreatic Surgery.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing distal pancreatectomy at Johns Hopkins Hospital

Exclusion Criteria:

• Children <18 years old, pregnant women, adults lacking capacity to consent, non-english speakers, and prisoners.

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
OTHER: Soft Pancreatic Gland; This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.	Device: Jackson-Pratt Drain; A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"; Device: Non-suctioning drainage; A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
OTHER: Hard Pancreatic Gland; This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope.	Device: Jackson-Pratt Drain; A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"; Device: Non-suctioning drainage; A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pancreatic Fistula	The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.	90 days

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Christopher L Wolfgang, MD PHD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2013
• Primary Completion (ACTUAL): February 15, 2021
• Study Completion (ACTUAL): February 20, 2021

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (ESTIMATE): January 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatic Fistula
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: NA_00080937; IRB00197557 (OTHER: Johns Hopkins IRB)