Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Study Overview
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Brief Summary
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The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.

Official Title
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Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study

Conditions
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Gastric Cancer, GastroEsophageal Cancer

Intervention / Treatment
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* Procedure: Double tract anatomosis
* Procedure: Esophagogastrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as gastric or esophagogastric adenocarcinoma Age ranges from 18 to 80 Karnofsky assessment no less than 70 Completion of abdominal CT scan and ultrasound endoscopy Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm) radical proximal gastrectomy Normal blood routine examination and biochemical test Exclusion Criteria: Patients need to undergo total gastrectomy or distal gastrectomy Female patients with pregnancy Not suitable for operation Patients have already joined other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double tract anatomosis<br>After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers. | Procedure: Double tract anatomosis<br>* After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.<br>|
| Active Comparator: Esophagogastrostomy<br>After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler. | Procedure: Esophagogastrostomy<br>* After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reflux esophagitis after operation | The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative quality of life | Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome. | 12months | 
| postoperative quality of life | Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome. | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer