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Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07635836
Enrollment
52
Registered
2026-06-09
Start date
2026-05-01
Completion date
2027-10-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Double-tract Reconstruction, Gastric Cancer (GC), Tubular Gastric Anastomosis

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.

Interventions

PROCEDUREDouble-tract reconstruction

Patients underwent double-tract reconstruction after radical proximal gastrectomy

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative reflux esophagitis6 month after surgeryThe diagnosis of reflux esophagitis was based on symptoms, endoscopic findings, and 24-hour esophageal pH monitoring.
Severity of reflux esophagitis6 month after surgeryAccording to the diagnostic and grading criteria for reflux esophagitis, patients were classified into four categories: no reflux esophagitis, mild (LA-A/B), moderate (LA-C), and severe (LA-D).

Secondary

MeasureTime frameDescription
Postoperative nutritional recovery1 year after surgeryThe body weight change rate at different postoperative time points compared with preoperative levels, along with albumin, prealbumin, and hemoglobin levels, were comprehensively considered in the assessment of postoperative nutritional status.

Countries

China

Contacts

CONTACTHui Qu, Doctor of Medicine
doctorquhui@email.sdu.edu.cn+8618560085120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026