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

Not Applicable

Terminated

• Conditions: Pancreatic Fistula
• Interventions: Device: Jackson-Pratt Drain; Device: Non-suctioning drainage

• Registration Number: NCT02343302
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-20
• Status Verified: 2021-03
• Results First Submitted: 2021-11-22
• Results First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Results First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soft Pancreatic Gland	Jackson-Pratt Drain	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.
Soft Pancreatic Gland	Non-suctioning drainage	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.
Hard Pancreatic Gland	Jackson-Pratt Drain	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.
Hard Pancreatic Gland	Non-suctioning drainage	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States