Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

Study Overview
=================
Brief Summary
-----------------
Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity. Furthermore, blood perfusion significantly decreases after tubular gastric surgery.

Detailed Description
-----------------
Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ). There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate. On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube

Official Title
-----------------
Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Narrow gastric tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic finding by esophageal endoscopy: confirmed esophageal cancer. Indication for esophagectomy Age: 18 - 80 year old Tumor located at the middle or lower third of the esophagus ASA score: ≤ 3 Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer Pregnant patient Using colon or intesinal conduit

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subtotal stomach<br>The vessels at the anastomosis of right and left gastric arteries were separated, then the proximal haft of lesser curvature and cardia was resected using linear staplers. | Procedure: Narrow gastric tube<br>* At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler<br>|
| Active Comparator: Narrow gastric tube<br>At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler. | Procedure: Narrow gastric tube<br>* At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications (30-day complications): rate of anastomotic leakage | Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early complications (30-day complications): rate of anastomotic stricture | Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early complications (30-day complications): rate of bleeding | Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early complications (30-day complications): rate of pneumonia | Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early complications (30-day complications): rate of mortality. | Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early complications (30-day complications): rate of reoperation. | Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification. | 30 days after surgery | 
| Early outcomes (30-day post operative): length of hospital stay. | Comparison of the length of hospital stay. | 30 days after surgery | 
| Early outcomes (30-day post operative): day of oral intake. | Comparison of the day of oral intake. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nutritional status: body weight | Comparison of body weight at 6, 12 months and every year after surgery | 6, 12 months and 1 year after surgery | 
| Postoperative nutritional status: serum total protein | Comparison of serum total protein at 6, 12 months and every year after surgery | 6, 12 months and 1 year after surgery | 
| Postoperative nutritional status: albumin level | Comparison of albumin level at 6, 12 months and every year after surgery | 6, 12 months and 1 year after surgery | 
| Postoperative nutritional status: hemoglobin | Comparison of hemoglobin at 6, 12 months and every year after surgery | 6, 12 months and 1 year after surgery | 
| Reflux esophagitis | Reflux esophagitis will be evaluated using the Los Angeles classification at 6, 12 months and every year after surgery | 6, 12 months and 1 year after surgery | 
| Residue Gastritis Bile | RGB (Residue Gastritis Bile) classification will be used to evaluate status of remnant stomach 6 to 12 months after surgery | 6, 12 months and 1 year after | 
| Patients' health-related quality of life | Patients' health-related quality of life will be evaluated using GSRS (Gastrointestinal Symptom Rating Scale) score at 6, 12 months and every year after surgery | 6, 12 months and 1 year after | 
| Late complications: anastomotic stricture | Comparison of the rate anastomotic stricture complications during the follow-up period | 6, 12 months and 1 year after | 
| Late complications: anastomotic ulcer | Comparison of anastomotic ulcer during the follow-up period | 6, 12 months and 1 year after | 
| Others late complications | Comparison of other late complications during the follow-up period | 6, 12 months and 1 year after | 
| Oncological outcomes: overall survival rate | Comparison of overall survival rate during the follow-up period | 6, 12 months and 1 year after | 
| Oncological outcomes: rate of death due to the cancer | Comparison of rate of death due to the cancer, and death from all causes during the follow-up period | 6, 12 months and 1 year after | 
| Oncological outcomes: recurrence, metastasis | Comparison of recurrence, metastasis during the follow-up period | 6, 12 months and 1 year after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subtotal stomach, narrow gastric tube, anastomosis