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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

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.

Condition or disease Intervention/treatment Phase
Postprocedural Delayed Gastric Emptying Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
Study Start Date : November 2011
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: gastrointestinal reconstruction 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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460550


Contacts
Contact: Ippei Matsumoto, MD +81-78-382-6302 imatsu@med.kobe-u.ac.jp

Locations
Japan
Kobe University Recruiting
Kobe, Hyogo, Japan, 6500017
Contact: Ippei Matsumoto, MD    +81-78382-6302    imatsu@med.kobe-u.ac.jp   
Sponsors and Collaborators
Kobe University
Investigators
Study Chair: Yonson Ku, MD Kobe University

Additional Information:
Publications:

Responsible Party: Ippei Matsumoto, Associate Professor, Kobe University
ClinicalTrials.gov Identifier: NCT01460550     History of Changes
Other Study ID Numbers: KOPAS01
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Ippei Matsumoto, Kobe University:
delayed gastric emptying(DGE)
pancreaticoduodenectomy(PD)
randomized controlled trial(RCT)
gastro- or duodeno- jejunostomy reconstruction
morbidity

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms