Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

March 19, 2024 updated by: Yunhong Tian, Nanchong Central Hospital
This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Yunhong Tian
        • Contact:

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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
  2. Eastern Cooperative Oncology Group performance status of 0 or 1.
  3. Adequate organ function.

Exclusion Criteria:

  1. Patients had distant metastasis.
  2. oesophageal invasion of more than 3 cm.
  3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
  4. Previous chemotherapy or radiation therapy for any other malignancies.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.
Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure
Active Comparator: Control
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.
Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophagus reflux disease apprised by ph monitoring
Time Frame: 6 months
Ph monitoring by wireless or wire device
6 months
Gastroesophagus reflux disease apprised by questionnaire
Time Frame: 6 months
PGSAS-45 questionnaire is adopted.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications of proximal gastrectomy for gastric cancer
Time Frame: 1 year
Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.
1 year
Long-term outcome
Time Frame: 5 years
Total survival time after proximal gastrectomy for gastric cancer
5 years

Collaborators and Investigators

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

Sponsor

Nanchong Central Hospital

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)

January 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220720

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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