Comparison of Channel Esophagogastrostomy and Double Tract Reconstruction After Laparoscopic-assist Proximal Gastrectomy: a Propensity Score-Matched Analysis

Completed

• Conditions: Gastric (Stomach) Cancer

• Registration Number: NCT06741124
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief Summary

This retrospective cohort study enrolled adult patients who underwent LAPG between September 2020 and September 2023 at Northern Jiangsu People's Hospital. Patients were categorized into the CE group (CE anastomosis) and the DTR group (DTR anastomosis) based on the digestive tract reconstruction method after LAPG. Variables such as sex and BMI may influence the technical difficulty and clinical outcomes of LAPG. To minimize bias, propensity score (PS) matching was performed at a 1:2 ratio between the CE group and the DTR group.

Detailed Description

This retrospective cohort study enrolled adult patients who underwent LAPG between September 2020 and September 2023 at Northern Jiangsu People's Hospital. This study was approved by the Medical Ethics Committee of Northern Jiangsu People's Hospital, and the requirement for written informed consent was waived due to the retrospective study design. This study adhered to the STROCSS 2021 guidelines and was conducted in accordance with the Declaration of Helsinki. The inclusion criteria were as follows: (1) Patients with a malignant tumor in the upper one-third of the stomach, diagnosed through endoscopy and pathology, with no distant metastases confirmed by multislice spiral computed tomography, and who underwent elective LAPG; (2) Patients who underwent CE reconstruction or DTR during LAPG; and (3) Patients available for postoperative follow-up. The exclusion criteria were as follows: (1) Patients who had received neoadjuvant radiotherapy or chemotherapy prior to surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignancies; (4) Lost to follow-up patients. All surgeries were conducted by the same surgical team. Before the procedure, patients were comprehensively informed about their condition and the surgical approach. After a detailed explanation of the two digestive tract reconstruction methods, the choice between CE or DTR anastomosis was made in accordance with each patient's preference. Patients were categorized into the CE group (CE anastomosis) and the DTR group (DTR anastomosis) based on the digestive tract reconstruction method after LAPG. Variables such as sex and BMI may influence the technical difficulty and clinical outcomes of LAPG. To minimize bias, propensity score (PS) matching was performed at a 1:2 ratio between the CE group and the DTR group, based on age, sex, preoperative BMI, American Society of Anesthesiologists (ASA) score, and history of abdominal surgery.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

(1) Patients with a malignant tumor in the upper one-third of the stomach, diagnosed through endoscopy and pathology, with no distant metastases confirmed by multislice spiral computed tomography, and who underwent elective LAPG; (2) Patients who underwent CE reconstruction or DTR during LAPG; and (3) Patients available for postoperative follow-up.

Exclusion Criteria

(1) Patients who had received neoadjuvant radiotherapy or chemotherapy prior to surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignancies; (4) Lost to follow-up patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic reflux esophagitis	Postoperative one year	Los Angeles classification

Secondary Outcome Measures

Name	Time	Method
PGSAS-45 questionnaires	Postoperative one year	Postgastrectomy syndrome assessment scale (PGSAS-45) developed by the Japanese Post-Gastrectomy Symptom Assessment Study Group, is used to objectively evaluate postoperative symptom, quality of life of patients after gastrectomy. It reflects symptoms in seven areas: gastroesophageal reflux, abdominal pain, meal-related distress, dyspepsia, diarrhea, constipation, and dumping syndrome.

Trial Locations

Locations (1)

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou City, Jiangsu, China