Preliminary Efficacy Analysis of 'λ+α' Double-Tract Reconstruction After Laparoscopic Proximal Gastrectomy

Laparoscopic Proximal Gastrectomy With 'λ+α' Double-Tract Reconstruction for Upper-Third Early 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, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for GI reconstruction, i.e., the "λ+α dual-channel anastomosis". This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Reflux Esophagitis
• Intervention / Treatment: Procedure: proximal gastrectomy combined with 'λ+α' double-tract anastomosis

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daorong Wang; Phone Number: 18051062590; Email: wdaorong666@sina.com

Study Locations

• China
  • Yangzhou, China
    • Recruiting
    • Northern Jiangsu People's Hospital
    • Contact: Daorong Wang; Phone Number: 18051062590; Email: wdaorong666@sina.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Age between 18-75 years old, male or female; 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) (14) according to the eighth edition of the AJCC (15); No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT; ASA grade 1-3; Patients without contraindications to surgery; Patients and their families voluntarily signed the informed consent form and participated in the study;

Exclusion Criteria:

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

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: λ+α double-tract anastomosis	Procedure: proximal gastrectomy combined with 'λ+α' double-tract anastomosis; 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.; The jejunum is dissected 30 cm from the flexor ligament and the distal jejunum is lifted in an anterior colonic direction to the esophageal dissection.; Esophagojejunal anastomosis at 16 cm from the distal jejunal stump；; Residual gastrojejunostomy at 8 cm from the distal jejunal stump；
Active Comparator: double-tract anastomosis	Procedure: proximal gastrectomy combined with 'λ+α' double-tract anastomosis; 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.; The jejunum is dissected 30 cm from the flexor ligament and the distal jejunum is lifted in an anterior colonic direction to the esophageal dissection.; Esophagojejunal anastomosis at 16 cm from the distal jejunal stump；; Residual gastrojejunostomy at 8 cm from the distal jejunal stump；

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.	12 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
incidence of anastomotic stenosis	The percentage (%) of patients developing anastomotic stenosis after surgery in each group.	12 months after surgery
operative time	The duration, measured in minutes, spent on reconstructing the digestive tract using different reconstruction methods	1 day after surgery

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Stomach Neoplasms; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: NorthernJiangsu1

Drug and device information, study documents

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