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

Laparoscopic Proximal Gastrectomy with "C" Single Flap Plasty Reconstruction for Upper-Third Gastric Cancer: a Randomized Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Reflux Esophagitis
• Intervention / Treatment: Procedure: "C" Single Flap Plasty Reconstruction; Procedure: Normal Reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daorong Wang, Doctor; Phone Number: 8618051062590; Email: wdaorong666@sina.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225000
      • Northern Jiangsu People's Hospital
      • Contact: Daorong Wang, doctor; Phone Number: 0514-87373114; Email: wdaorong666@sina.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age between 18-80 years old, male or female;
2. Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) according to the eighth edition of the AJCC ;
3. No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT;
4. ASA grade 1-3;
5. Patients without contraindications to surgery;
6. Patients and their families voluntarily signed the informed consent form and participated in the study;

Exclusion Criteria:

1. Patients diagnosed with primary tumors or distant metastasis;
2. Patients whose tumor is located in the greater curvature side of the stomach;
3. Patients with coagulation dysfunction that could not be corrected;
4. Patients who were diagnosed with viral hepatitis and cirrhosis;
5. Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
6. Patients with organ failure such as heart, lung, liver, brain, and kidney failure;
7. Patients with ascites or cachexia preoperatively in poor general conditions;
8. Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
9. Patients refusing to sign the informed consent of the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "C" Single Flap Plasty Reconstruction; 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.; 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.; 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.	Procedure: "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; 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.; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of reflux esophagitis	The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of anastomotic leakage	The percentage (%) of patients developing postoperative anastomotic leakage after surgery in each group.	30 days after surgery

Collaborators and Investigators

• Sponsor: Daorong Wang

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Gastroenteritis; Duodenal Diseases; Peptic Ulcer; Stomach Neoplasms; Esophagitis; Esophagitis, Peptic
• Other Study ID Numbers: northernjiangsu007

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
• product manufactured in and exported from the U.S.: No