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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Ippei Matsumoto, Kobe University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460550
First Posted: October 27, 2011
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ippei Matsumoto, Kobe University
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ippei Matsumoto, Kobe University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:

Responsible Party: Ippei Matsumoto, Associate Professor, Kobe University
ClinicalTrials.gov Identifier: NCT01460550     History of Changes
Other Study ID Numbers: KOPAS01
First Submitted: October 11, 2011
First Posted: October 27, 2011
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