Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 21, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 31, 2026
March 1, 2026
7 years
August 21, 2022
March 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Gastroesophagus reflux disease apprised by ph monitoring
Ph monitoring by wireless or wire device
6 months
Gastroesophagus reflux disease apprised by questionnaire
PGSAS-45 questionnaire is adopted.
6 months
Secondary Outcomes (2)
Surgical complications of proximal gastrectomy for gastric cancer
1 year
Long-term outcome
5 years
Study Arms (2)
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)
EXPERIMENTALThe reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.
Control
ACTIVE COMPARATORThe reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.
Interventions
The location of the anastomosis in the anterior of the gastric stump. Pyloroplasty is added in the procedure
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yunhong Tian
Nanchong, Sichuan, 637000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 21, 2022
First Posted
August 24, 2022
Study Start
January 1, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03