Trial record 20 of 33 for:    Open Studies | "Gastroparesis"

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

This study is currently recruiting participants.
Verified June 2012 by Kobe University
Sponsor:
Information provided by (Responsible Party):
Ippei Matsumoto, Kobe University
ClinicalTrials.gov Identifier:
NCT01460550
First received: October 11, 2011
Last updated: June 14, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Kobe University:

Primary Outcome Measures:
  • Incident rate of delayed gastric emptying [ Time Frame: during hospital stay after surgery, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    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 2014
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 11, 2011
Last Updated: June 14, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014