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

Johns Hopkins University

Status: Terminated

Conditions: Pancreatic Fistula

Treatments: Device: Jackson-Pratt Drain; Device: Non-suctioning drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02343302

IRB00197557 (Other Identifier)

NA_00080937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Soft Pancreatic Gland

Other group

Description:

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.

Treatment:

Device: Non-suctioning drainage

Device: Jackson-Pratt Drain

Hard Pancreatic Gland

Other group

Description:

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.

Treatment:

Device: Non-suctioning drainage

Device: Jackson-Pratt Drain