NCT02343302

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
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"

Timeline

• Start date: 2013-02-01
• Primary completion: 2021-02-15
• Completion: 2021-02-20
• First posted: 2015-01-21
• Last updated: 2021-12-21
• Results posted: 2021-12-21

Locations

1 site across 1 country: United States