Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Double-tract reconstruction
Procedure/SurgeryPatients underwent double-tract reconstruction after radical proximal gastrectomy
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: DTR GroupExperimental treatment 1 intervention
Group B: TGA GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of postoperative reflux esophagitis
The diagnosis of reflux esophagitis was based on symptoms, endoscopic findings, and 24-hour esophageal pH monitoring.
Time frame
6 month after surgery2
Severity of reflux esophagitis
According 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).
Time frame
6 month after surgerySecondary outcomes
1
Postoperative nutritional recovery
The 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.
Time frame
1 year after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov