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

Kobe University

Status and phase: Unknown; Phase 3

Conditions: Postprocedural Delayed Gastric Emptying

Treatments: Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy; Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01460550

KOPAS01

Details and patient eligibility

About

The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

gastrointestinal reconstruction

Experimental group

Treatment:

Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy

Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy