Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

NCT01384617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-07-21

No results posted yet for this study

Summary

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

Conditions

  • Pancreatic Cancer
  • Pancreatic Cystic Lesions
  • Chronic Pancreatitis
  • Pancreatic Neuroendocrine Tumors
  • Pancreatic Pseudocysts

Interventions

PROCEDURE

Stapling closure of the pancreatic stump

Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.

PROCEDURE

Roux-en-Y anastomosis of the pancreatic stump

end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Sponsors & Collaborators

  • Osaka University

    collaborator OTHER
  • Nara Medical University

    collaborator OTHER
  • Kyoto Prefectural University of Medicine

    collaborator OTHER
  • Kansai Rosai Hospital

    collaborator OTHER
  • Hyogo Medical University

    collaborator OTHER
  • Wakayama Medical University

    lead OTHER

Principal Investigators

  • Manabu Kawai, MD · Wakayama Medical University, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-06-30
Completion
2016-06-30

Countries

  • Japan

Study Locations

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Entities

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 NCT01384617 on ClinicalTrials.gov