Comparison of Double-tract Reconstruction and Tubular Gastric Anastomosis
for Proximal Gastric Cancer Surgery
Evaluating Postoperative Reflux and Quality of Life
Led by Qilu Hospital of Shandong University · Updated on 2026-06-09
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with proximal gastric cancer, specifically those with Siewert type II or III tumors at clinical stages cT1-3N0-1M0. The study compares two surgical methods, double-tract reconstruction and tubular gastric anastomosis, to evaluate their effects on postoperative outcomes including reflux esophagitis and quality of life. This research is conducted across six tertiary hospitals with randomized group assignments.
Participants undergo radical proximal gastrectomy followed by either double-tract reconstruction or tubular gastric anastomosis, depending on their assigned group. The interventions are surgical procedures aimed at restoring digestive tract continuity. The study collects data on postoperative reflux using gastroscopy and 24-hour esophageal pH monitoring, alongside rating scales to assess severity and impact.
During the study, participants are monitored for reflux esophagitis incidence and severity six months after surgery. Nutritional recovery is also assessed one year postoperatively. Researchers review electronic medical records and conduct scheduled examinations to measure outcomes. The total study duration includes preoperative assessment, surgery, and follow-up evaluations extending up to one year after surgery.
CONDITIONS
Brief Title
Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer
Research Team
H
Hui Qu, Doctor of Medicine
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Pathologically confirmed gastric adenocarcinoma by biopsy
Carcinoma of the upper gastric body or Siewert type II/III adenocarcinoma of the esophagogastric junction with clinical stage cT1-3N0-1M0
Age between 18 and 75 years with a performance status score of 0-2
Eligible for planned surgical resection with either double-tract reconstruction or tubular gastric anastomosis
No severe dysfunction of vital organs or severe infection or uncontrolled chronic diseases
You will not qualify if you...
Presence of other malignant tumors or severe chronic diseases such as severe diabetes mellitus, chronic kidney disease, or decompensated cirrhosis
Preoperative endoscopic diagnosis of Barrett's esophagus
Severe preoperative malnutrition with albumin less than 30 g/L or prealbumin less than 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day and immediate postoperative period
Participants undergo radical proximal gastrectomy followed by either double-tract reconstruction or tubular gastric anastomosis as assigned.
Hospital stay as required for surgery and recovery
Follow-up
Duration - 12 months after surgery
Participants are monitored for postoperative reflux esophagitis and nutritional recovery through scheduled tests and evaluations up to one year after surgery.
Follow-up visits including gastroscopy and 24-hour pH monitoring at 6 months, nutritional assessments at 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Comparison on the reflux and nutritional status of different reconstruction methods after laparoscopic proximal gastrectomy: a systematic review and network meta-analysis.
A 3-Arm case-matched analysis of anti-reflux reconstruction methods after laparoscopic proximal gastrectomy - Single tract jejunal interposition vs double tract reconstruction vs tube-like stomach reconstruction.
Comparison of channel esophagogastrostomy and double tract reconstruction after laparoscopic-assisted proximal gastrectomy: a propensity score-matched analysis.
Current status of treatment for esophagojejunostomy leakage after total gastrectomy in patients with gastric cancer: a multicenter retrospective study in Korea.