A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
Primary Purpose
Postprocedural Delayed Gastric Emptying
Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
Sponsored by
About this trial
This is an interventional prevention trial for Postprocedural Delayed Gastric Emptying focused on measuring delayed gastric emptying(DGE), pancreaticoduodenectomy(PD), randomized controlled trial(RCT), gastro- or duodeno- jejunostomy reconstruction, morbidity
Eligibility 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
Sites / Locations
- Kobe UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastrointestinal reconstruction
Arm Description
Outcomes
Primary Outcome Measures
Incident rate of delayed gastric emptying
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01460550
Brief Title
A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
Official Title
Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kobe University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Delayed Gastric Emptying
Keywords
delayed gastric emptying(DGE), pancreaticoduodenectomy(PD), randomized controlled trial(RCT), gastro- or duodeno- jejunostomy reconstruction, morbidity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gastrointestinal reconstruction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
Intervention Description
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 Measure Information:
Title
Incident rate of delayed gastric emptying
Description
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.
Time Frame
during hospital stay after surgery, an expected average of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ippei Matsumoto, MD
Phone
+81-78-382-6302
Email
imatsu@med.kobe-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonson Ku, MD
Organizational Affiliation
Kobe University
Official's Role
Study Chair
Facility Information:
Facility Name
Kobe University
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ippei Matsumoto, MD
Phone
+81-78382-6302
Email
imatsu@med.kobe-u.ac.jp
12. IPD Sharing Statement
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Links:
URL
http://www.med.kobe-u.ac.jp/hbps/index.html
Description
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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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