Pancreatic Duct Stenting to Prevent Postoperative Pancreatic Fistula (POPF) After Distal Pancreatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-04

Study Completion Date

2020-01-31

Brief Summary

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To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact the incidence of a post-operative pancreatic fistula, as defined by postoperative. If pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly decrease the rate of development of a post-operative pancreatic fistula after distal pancreatectomy.

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Detailed Description

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Prophylactic pancreatic duct stenting is to be offered to all patients deemed a candidate for a distal pancreatectomy. This is a nonrandomized cohort study with a retrospective and prospective control group (Jan 2008 - Dec 2017 or sample size obtained) and a prospective endoscopic intervention group (September 2015 - Dec 2017 or until sample size obtained). We will then compare the rate of development of a postoperative pancreatic fistula between those patients who have preoperative stenting and those who do not. POPF will be defined as the amylase level of drain contents equaling three times or more the serum amylase on postoperative day 3, as defined by the International Study Group for Pancreatic Fistula (ISGPF) or an ICD-9 diagnosis of 577.8. The patient will have a pre-operative visit for stent placement and a post-operative visit for stent removal if still in place 4-6 weeks after distal pancreatectomy.

Conditions

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Pancreatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Retrospective and prospective "non-stented"

Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017.

Group Type NO_INTERVENTION

No interventions assigned to this group

Prospective "stented"

Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.

Group Type EXPERIMENTAL

Boston Scientific or Cook pancreatic duct stents

Intervention Type DEVICE

Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in.

Interventions

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Boston Scientific or Cook pancreatic duct stents

Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients age 18 years of age and older
2. Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas.

Exclusion Criteria

1. Pediatric patients younger than age 18
2. Pregnant patients
3. Patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No