Clinical trial NCT01460550: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postprocedural Delayed Gastric Emptying
Keywords: delayed gastric emptying(DGE)
pancreaticoduodenectomy(PD)
randomized controlled trial(RCT)
gastro- or duodeno- jejunostomy reconstruction
morbidity
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incident rate of delayed gastric emptying
timeFrame: during hospital stay after surgery, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
Study officials:
affiliation: Kobe University
name: Yonson Ku, MD
role: STUDY_CHAIR
References:
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