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Completed

NCT Number: NCT06741124

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Channel Esophagogastrostomy

Procedure

Channel Esophagogastrostomy

Double tract reconstruction

Procedure

Double Tract Reconstruction

Primary outcomes

  1. Endoscopic reflux esophagitis

    Time frame: Postoperative one year

    Los Angeles classification

Secondary outcomes

  1. PGSAS-45 questionnaires

    Time frame: 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.

Other outcomes

  1. Nutritions status

    Time frame: Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,

    alb, hb,

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 18, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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