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

• Sponsor: Nanchong Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05514769
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Proximal Gastric Adenocarcinoma; Gastric Cancer; Gastroesophageal Reflux Disease	Procedure: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gastroesophagus reflux disease apprised by ph monitoring [6 months]

   Ph monitoring by wireless or wire device

2. Gastroesophagus reflux disease apprised by questionnaire [6 months]

   PGSAS-45 questionnaire is adopted.

Secondary Outcome Measures

1. Surgical complications of proximal gastrectomy for gastric cancer [1 year]

   Surgical complications include anastomotic leakage, anastomotic stricture, postoperative bleeding, pleural effusion, et al.

2. Long-term outcome [5 years]

   Total survival time after proximal gastrectomy for gastric cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunhong Tian	Nanchong	Sichuan	China	637000

Sponsors and Collaborators

• Nanchong Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yunhong Tian, Professor, Nanchong Central Hospital
• ClinicalTrials.gov Identifier: NCT05514769
• Other Study ID Numbers: 20220720
• First Posted: Aug 24, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms; Gastroesophageal Reflux

Study Results

No Results Posted as of Aug 24, 2022