A Modified Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Gastric Adenocarcinoma; Anastomosis; Adenocarcinoma of Esophagogastric Junction
• Intervention / Treatment: Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinkui Wang, MD PHD; Phone Number: 0086-10-88196606; Email: wykchangfeng@pku.edu.cn
• Study Contact Backup: Name: Ziyu Li, MD PHD; Phone Number: 0086-10-88196605; Email: ziyu_li@hsc.pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Ziyu Li
      • Sub-Investigator: Yinkui Wang, M.D.
      • Contact: Yinkui Wang, MD PHD; Phone Number: 0086-10-88196606; Email: wykchangfeng@pku.edu.cn
      • Contact: Ziyu Li, MD PHD; Phone Number: 0086-10-88196605; Email: ziyu_li@hsc.pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: "arch-bridge-type" reconstruction arm; In this arm, patients will receive proximal gastrectomy and "arch-bridge-type" reconstruction.

Procedure: "arch-bridge-type" esophagogastric reconstruction after proximal gastrectomy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Ziyu Li, MD PHD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2023YJZ11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No