Clinical Trials

The James Cancer Center Columbus, OH

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Surgery With or Without Intraperitoneal Drainage in Improving Complication Rate in Patients With Pancreatic Disease

Protocol: OSU-11113

Full Title

A Randomized Prospective Multicenter Trial of Pancreas Resection with and without Routine Intraperitoneal Drainage

Purpose

This randomized clinical trial studies surgery with or without intraperitoneal drainage in improving complication rate in patients with pancreatic disease. Surgery without intraperitoneal drainage may improve complication rate in patients with pancreatic disease.

Study Objective

PRIMARY OBJECTIVES:

I. Difference in 60-day >= grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

SECONDARY OBJECTIVES:

I. 60-day >= grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

II. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

III. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

IV. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

V. 60-day and 90-day mortality rate comparison between patients who receive a pancreatotomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

VI. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

VII. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

VIII. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

IX. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo pancreatic resection with intraperitoneal drainage.

ARM II: Patients undergo pancreatic resection.

After completion of study treatment, patients are followed up at 90 days.

Are you eligible?

Inclusion Criteria:

The subject has a surgical indication for distal pancreatectomy

In the opinion of the surgeon, the subject has no medical contraindications to distal pancreatectomy

The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group

The subject is willing to comply with 30-day follow-up in the office and answer quality-of-life questionnaires per protocol

The subject is willing to comply with 90-day follow-up by phone

Exclusion Criteria:

Patients who require any type of pancreas resection other than a distal pancreatectomy

In the opinion of the surgeon, the subject has medical contraindications to distal pancreatectomy

The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group

The subject is not willing to comply with 60-day follow-up in the office and answer quality-of-life questionnaires per protocol

The subject is not willing to comply with 90-day follow-up by phone

Pancreatic Cancer Gastrointestinal Cancers