Preliminary Efficacy Analysis of "C" Single Flap Plasty Reconstruction After Laparoscopic Proximal Gastrectomy

Sponsor
Daorong Wang
Study ID
NCT06741501
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • "C" Single Flap Plasty Reconstruction — PROCEDURE
    1\. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux.
  • Normal Reconstruction — PROCEDURE
    1\. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques.

Study Details

The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2024
Primary completion
Mar 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "C" Single Flap Plasty Reconstruction
    1. C-shaped flap creation: A 3.0 cm wide by 3.5 cm high "C"-shaped flap is marked on the anterior gastric wall, 1.5-2.5 cm distal to the stomach transection line. The flap is created by carefully separating the submucosa from the muscular propria using an electric scalpel, forming a left-opening flap. This flap will later be used to cover the anastomotic site. 2. Esophagogastric anastomosis: The esophagus and stomach are anastomosed intracorporeally. After continuous suturing of the posterior esophageal wall to the remnant stomach, the common opening between the esophagus and the stomach is closed. 3. Flap coverage: After anastomosis, the C-shaped flap is sutured over the anastomotic site, reinforcing it by covering both the esophageal stump and the gastric window, which helps prevent complications like leakage or reflux.
  • Active Comparator: Normal Reconstruction
    1. Preparation of the Remnant Stomach and Esophagus: After the resection of the proximal stomach, the remaining stomach is prepared for direct anastomosis with the esophagus. The esophageal stump and gastric stump are aligned, typically without additional modifications to the gastric wall. 2. End-to-End or End-to-Side Anastomosis: The esophagus is directly connected to the remnant stomach, either in an end-to-end or end-to-side fashion, using a stapler or manual suturing techniques.

Primary Outcome Measure

incidence of reflux esophagitis [ Time Frame: 6 months after surgery ]

Central Contacts

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