Pancreas Resection With and Without Drains

The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have
traditionally placed drains near the pancreatic anastomosis to control this potentially very
serious complication. In recent years, advances in interventional radiology have allowed safe
percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the
routine use of prophylactic drains placed at the time of pancreas resection and rely on
percutaneous drainage for the minority of patients who develop a pancreatic fistula.

Hypothesis:

This randomized prospective trial is designed to test the hypothesis that pancreatectomy
without routine intraperitoneal drainage does not increase the severity or frequency of
complications within 60 days of surgery. The primary endpoint to assess the severity of
complications will be the number of patients with any ≥ Grade II complication. Severity of
complications experienced will also be assessed by comparing the number of patients with, any
≥ Grade III complication, any serious adverse event (SAE), and the median complication
severity grade of all complications. The frequency of complications will be assessed by
comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any
severity grade.

Objectives:

Primary: 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:

A. 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.

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

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

D. 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.

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

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

G. 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.

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

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

Inclusion Criteria:

- The subject has a surgical indication for distal pancreatectomy.

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

- At least 18 years of age.

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

- The subject is willing to comply with 90-day follow-up and answer quality-of-life
questionnaires per protocol.

Exclusion Criteria:

- The subject does not have a surgical indication for distal pancreatectomy.

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

- Less than 18 years of age.

- 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 90-day follow-up and answer quality-of-life
questionnaires per protocol.