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

Primary Purpose

Proximal Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Reflux Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
Sponsored by
Nanchong Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yunhong TianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)

Control

Arm Description

The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.

The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.

Outcomes

Primary Outcome Measures

Gastroesophagus reflux disease apprised by ph monitoring
Ph monitoring by wireless or wire device
Gastroesophagus reflux disease apprised by questionnaire
PGSAS-45 questionnaire is adopted.

Secondary Outcome Measures

Surgical complications of proximal gastrectomy for gastric cancer
Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.
Long-term outcome
Total survival time after proximal gastrectomy for gastric cancer

Full Information

First Posted
August 21, 2022
Last Updated
March 13, 2023
Sponsor
Nanchong Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05514769
Brief Title
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Official Title
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanchong Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Gastric Adenocarcinoma, Gastric Cancer, Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)
Arm Type
Experimental
Arm Description
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.
Intervention Type
Procedure
Intervention Name(s)
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty
Intervention Description
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure
Primary Outcome Measure Information:
Title
Gastroesophagus reflux disease apprised by ph monitoring
Description
Ph monitoring by wireless or wire device
Time Frame
6 months
Title
Gastroesophagus reflux disease apprised by questionnaire
Description
PGSAS-45 questionnaire is adopted.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgical complications of proximal gastrectomy for gastric cancer
Description
Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.
Time Frame
1 year
Title
Long-term outcome
Description
Total survival time after proximal gastrectomy for gastric cancer
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages. Eastern Cooperative Oncology Group performance status of 0 or 1. Adequate organ function. Exclusion Criteria: Patients had distant metastasis. oesophageal invasion of more than 3 cm. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma. Previous chemotherapy or radiation therapy for any other malignancies.
Facility Information:
Facility Name
Yunhong Tian
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhong Tian, PHD
Phone
13508087719
Email
drtianyunhong@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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