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

Phase 3

• Conditions: Postprocedural Delayed Gastric Emptying
• Interventions: Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy; Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy

• Registration Number: NCT01460550
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Study Start: 2011-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01
• Primary Completion: 2016-10
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gastrointestinal reconstruction	Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy	-
gastrointestinal reconstruction	Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy	-

Primary Outcome Measures

Name	Time	Method
Incident rate of delayed gastric emptying	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.

Trial Locations

Locations (1)

Kobe University; 🇯🇵 Kobe, Hyogo, Japan