NCT06741124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
Last Updated

January 10, 2025

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

December 16, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Proximal GastrectomyChannel EsophagogastrostomyDouble Tract Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Endoscopic reflux esophagitis

    Los Angeles classification

    Postoperative one year

Secondary Outcomes (1)

  • PGSAS-45 questionnaires

    Postoperative one year

Other Outcomes (1)

  • Nutritions status

    Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,

Study Arms (2)

Channel Esophagogastrostomy (CE)

Patients who underwent Channel Esophagogastrostomy reconstruction

Procedure: Channel Esophagogastrostomy

Double Tract Reconstruction (DTR)

Patients who underwent DTR reconstruction during LAPG

Procedure: Double Tract Reconstruction

Interventions

Channel Esophagogastrostomy

Channel Esophagogastrostomy (CE)

Double Tract Reconstruction

Double Tract Reconstruction (DTR)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients who underwent LAPG between September 2020 and September 2023 at Northern Jiangsu People's Hospital. Patients who underwent CE reconstruction or DTR during LAPG;

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Related Publications (2)

  • Liu K, Yang K, Zhang W, Chen X, Chen X, Zhang B, Chen Z, Chen J, Zhao Y, Zhou Z, Chen L, Hu J. Changes of Esophagogastric Junctional Adenocarcinoma and Gastroesophageal Reflux Disease Among Surgical Patients During 1988-2012: A Single-institution, High-volume Experience in China. Ann Surg. 2016 Jan;263(1):88-95. doi: 10.1097/SLA.0000000000001148.

    PMID: 25647058BACKGROUND
  • Zhou J, Li R, Cheng Y, Zhao S, Wang J, Fu Y, Tian Z, Wang L, Wang W, Ren J, Wang D. Comparison of channel esophagogastrostomy and double tract reconstruction after laparoscopic-assisted proximal gastrectomy: a propensity score-matched analysis. Surg Endosc. 2025 Sep;39(9):5722-5732. doi: 10.1007/s00464-025-11978-w. Epub 2025 Jul 17.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 18, 2024

Study Start

September 1, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

January 10, 2025

Record last verified: 2020-09

Locations