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

January 8, 2025 updated by: Northern Jiangsu People's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhou City, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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;

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Channel Esophagogastrostomy (CE)
Patients who underwent Channel Esophagogastrostomy reconstruction
Procedure: Channel Esophagogastrostomy
Channel Esophagogastrostomy
Double Tract Reconstruction (DTR)
Patients who underwent DTR reconstruction during LAPG
Procedure: Double Tract Reconstruction
Double Tract Reconstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endoscopic reflux esophagitis
Time Frame: Postoperative one year
Los Angeles classification
Postoperative one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Postoperative one year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritions status
Time Frame: Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,
alb, hb,
Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Jiangsu People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NorthernJiangsuCEDTR
  • CEDTR (Other Identifier: CEDTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data that support the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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