Clinical Trials Directory

Trials / Completed

CompletedNCT06741124

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

Status
Completed
Phase
Study type
Observational
Enrollment
99 (actual)
Sponsor
Northern Jiangsu People's Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREChannel EsophagogastrostomyChannel Esophagogastrostomy
PROCEDUREDouble Tract ReconstructionDouble Tract Reconstruction

Timeline

Start date
2020-09-01
Primary completion
2023-09-01
Completion
2024-09-01
First posted
2024-12-18
Last updated
2025-01-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06741124. Inclusion in this directory is not an endorsement.