Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Study Overview
=================
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.

Official Title
-----------------
Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Procedure: Isoperistaltic
* Procedure: Antiperistaltic


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isoperistaltic<br>Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach | Procedure: Isoperistaltic<br>* Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach<br>|
| Experimental: Antiperistaltic<br>Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach | Procedure: Antiperistaltic<br>* Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dumping syndrome | Using Sigstad's score | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, gastrojejunostomy, isoperistaltic, antiperistaltic