Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Not Applicable

• Conditions: Stomach Neoplasms
• Interventions: Procedure: Antiperistaltic; Procedure: Isoperistaltic

• Registration Number: NCT02837874
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Detailed Description

Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Histologically confirmed adenocarcinoma in stomach
• Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
• Planned with gastrojejunostomy after gastrectomy
• Clinical stage T1N0M0 or T2N0M0
• ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
• ASA score class I-III (The American Society of Anesthesiologists)
• patient has given their written informed consent to participate in the study

Exclusion Criteria

• Simultaneously combined resection of other organ (including cholecystectomy)
• Active other malignancy
• Requiring total gastrectomy
• Chronic inflammatory bowel disease or other chronic disease related to bowel motility
• Uncontrolled diabetes or patients with diabetic complications
• Vulnerable patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiperistaltic	Antiperistaltic	Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
Isoperistaltic	Isoperistaltic	Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach

Primary Outcome Measures

Name	Time	Method
Dumping syndrome	12 months	Using Sigstad's score

Secondary Outcome Measures

Name	Time	Method
Gastritis	12 months	by endoscopic evaluation
long-term complication	from 1 month to 12 months	all kind of complication
Total score of quality of life questionnaire	12 months	by EORTC questionnaire
Body weight change	12 months	for evaluate nutritional status
Surgical complication	within 1 month	all kind of complication within 1 month

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of