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A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction

NCT01460550 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-04-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.

Conditions

  • Postprocedural Delayed Gastric Emptying

Interventions

PROCEDURE

Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy

The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the retrocolic reconstruction, the jejunal loop was anastomosed to the duodenum or stomach through a separate mesocolic window on the left of the middle colic vessels.

PROCEDURE

Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy

The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the antecolic reconstruction, the jejunal loop about 30 cm distal to the hepaticojejunostomy, was brought up anterior to the transverse colon and anastomosed to the duodenum or stomach.

Sponsors & Collaborators

  • Kobe University

    lead INDUSTRY

Principal Investigators

  • Yonson Ku, MD · Kobe University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-10-31
Completion
2017-03-31

Countries

  • Japan

Study Locations

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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 NCT01460550 on ClinicalTrials.gov