A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

Study Overview
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Brief Summary
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The double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Our surgical team devise a modified esophagogastric reconstructive method which we term the arch-bridge-type reconstruction based on the principle of DFT. The aim of this single-arm prospective study is to assess the safety and feasibility of the arch-bridge-type reconstruction after PG.

Detailed Description
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The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. Creating the seromuscular flap (arch-bridge): (1) The stomach is resected by a linear stapling device. (2) A 匚 shaped seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by dissecting submocosal and muscular layer of the anterior wall of the remnant stomach. (3) The opening of the flap is interrupted sutured by 4-0 absorbable suture, then the arch-bridge is created. 4.The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.

Official Title
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A Modified Arch-bridge-type Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

Conditions
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Proximal Gastric Adenocarcinoma, Adenocarcinoma of Esophagogastric Junction, Anastomosis

Intervention / Treatment
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* Procedure: arch-bridge-type esophagogastric reconstruction after proximal gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction diameter of the tumor less than 4cm ECOG performance status score ≤2 no distant metastasis informed consent is signed Exclusion Criteria: metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction remnant gastric cancer patient requires emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arch-bridge-type reconstruction arm<br>In this arm, patients will receive proximal gastrectomy and arch-bridge-type reconstruction. | Procedure: arch-bridge-type esophagogastric reconstruction after proximal gastrectomy<br>* The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor. Creating the seromuscular flap (arch-bridge) The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical safety | The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc. | From surgery day to 30 days after surgery | 
| Postoperative long-term quality of life (QoL) | The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative body weight status | Body weight loss will be recorded in outpatient. | 1 year after surgery | 
| Postoperative reflux esophagitis | Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification. | 1 year after surgery | 
| Refinement of surgery | During the operation, the whole process of the operation will be videotaped by laparoscopy, and after the operation, the change of the technical process of the operation was judged by comparing the operation in the video and the scheduled operation steps before the operation. In case of technical changes, the surgical team will communicate and discuss with the chief surgeon, and decide whether to adjust and optimize the surgical technique based on the postoperative situation of the patient, so as to form new technical details. Objective metrics include the total operative time, the time of esophagogastric anastomosis, the time of creating the arch-bridge, intraoperative blood loss, the number of retrieved lymph nodes will be collected. | From surgery day to 30 days after surgery | 
| Postoperative hemoglobin | Laboratory tests will be done to evaluate the level of hemoglobin. | 1 year after surgery |