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

NCT02343302 | Terminated Results DMC

• 2 other identifiers: NA_00080937IRB00197557
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Fistula

Keywords

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Morbidity

  90 days

Study Arms (2)

Soft Pancreatic Gland

OTHER

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; Device: Non-suctioning drainage

Hard Pancreatic Gland

OTHER

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; Device: Non-suctioning drainage

Interventions

Jackson-Pratt Drain DEVICE

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"

Hard Pancreatic Gland; Soft Pancreatic Gland

Non-suctioning drainage DEVICE

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"

Hard Pancreatic Gland; Soft Pancreatic Gland

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing distal pancreatectomy at Johns Hopkins Hospital

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Johns Hopkins University

sleung7@jhu.edu

410-955-7518

Study Officials

• Christopher L Wolfgang, MD PHD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: February 1, 2013
• Primary Completion: February 15, 2021
• Study Completion: February 20, 2021
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-03

Locations

US (1)