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Clinical Trials/NCT07635836
NCT07635836RecruitingNot Applicable

Comparison of Gastroesophageal Reflux and Quality of Life Between Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer Patients

Qilu Hospital of Shandong University1 site in 1 country52 target enrollmentStarted: May 1, 2026Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
52
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study includes patients diagnosed with proximal gastric cancer (Siewert type II/III, cT1-3N0-1M0) across six tertiary hospitals, who underwent either double-tract reconstruction (DTR) or tubular gastric anastomosis (TGA). Participants were divided into two groups based on the surgical procedure. We conducted a comparative analysis of postoperative outcomes by evaluating electronic medical records, postoperative gastroscopy, 24-hour esophageal pH monitoring, and relevant rating scales.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pathologically confirmed gastric adenocarcinoma by biopsy
  • •Carcinoma of the upper gastric body or Siewert type II/III adenocarcinoma of the esophagogastric junction (AEG), with a clinical stage of cT1-3N0-1M0
  • •Age 18-75 years, with a performance status (PS) score of 0-2
  • •Candidates for planned surgical resection, eligible for either double-tract reconstruction or tubular gastric anastomosis based on preoperative assessment
  • •No severe dysfunction of vital organs (liver, kidney, heart, lung, or brain), and no severe infection or uncontrolled chronic diseases

Exclusion Criteria

  • •Presence of other malignant tumors or severe chronic diseases (e.g., severe diabetes mellitus, chronic kidney disease, decompensated cirrhosis, etc.)
  • •Preoperative endoscopic diagnosis of Barrett's esophagus
  • •Severe preoperative malnutrition (albumin <30 g/L, prealbumin <150 mg/L)
  • •History of prior upper abdominal surgery, gastrointestinal malformation, or psychiatric disorders
  • •Preoperative diagnosis of obstructive motor disorders of the cardia (including achalasia spectrum disorders)
  • •Inability to cooperate with or complete the required postoperative examinations

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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