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

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ClinicalTrials.gov Identifier: NCT01460550
Recruitment Status : Unknown
Verified March 2015 by Ippei Matsumoto, Kobe University.
Recruitment status was:  Recruiting
First Posted : October 27, 2011
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Ippei Matsumoto, Kobe University

Tracking Information
First Submitted Date  ICMJE October 11, 2011
First Posted Date  ICMJE October 27, 2011
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
Incident rate of delayed gastric emptying [ Time Frame: during hospital stay after surgery, an expected average of 3 weeks ]
DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
Official Title  ICMJE Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
Brief 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.
Detailed Description

The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. Delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and QOL. We conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction.

The primary endpoint was defined as incidence of delayed gastric emptying by ISGPS criteria. The secondary endpoint was defined as incidence of other postoperative morbidity. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. Exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Postprocedural Delayed Gastric Emptying
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: gastrointestinal reconstruction
Interventions:
  • Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
  • Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 25, 2011)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy

Exclusion Criteria:

  • patients who have the history of gastrectomy
  • patients who have severe cardiorespiratory dysfunction
  • patients who have liver cirrhosis or are receiving dialysis
  • patients who were diagnosed inadequacy for this study by a physician
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460550
Other Study ID Numbers  ICMJE KOPAS01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ippei Matsumoto, Kobe University
Study Sponsor  ICMJE Kobe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yonson Ku, MD Kobe University
PRS Account Kobe University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP