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

NCT02573389 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Louis A DiFronzo, MD · Kaiser Permanente

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-04
Primary Completion
2019-12-31
Completion
2020-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573389 on ClinicalTrials.gov