A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

Not Applicable

Recruiting

• Conditions: Adenocarcinoma of Esophagogastric Junction; Anastomosis; Proximal Gastric Adenocarcinoma
• Interventions: Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy

• Registration Number: NCT05829213
• Lead Sponsor: Peking University

Brief Summary

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

1. The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines.

2. Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.

3. 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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"arch-bridge-type" reconstruction arm	"arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy	In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.

Primary Outcome Measures

Name	Time	Method
Postoperative long-term quality of life (QoL)	1 year after surgery	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.
Surgical safety	From surgery day to 30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative reflux esophagitis	1 year after surgery	Reflux esophagitis will be evaluated by gastroscopy. Reflux esophagitis was graded by the Los Angeles classification.
Postoperative body weight status	1 year after surgery	Body weight loss will be recorded in outpatient.
Postoperative hemoglobin	1 year after surgery	Laboratory tests will be done to evaluate the level of hemoglobin.
Refinement of surgery	From surgery day to 30 days after 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.

Trial Locations

Locations (1)

Ziyu Li; 🇨🇳 Beijing, Beijing, China