Recruiting NCT07635836
Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double-tract reconstruction.
- Who it may be relevant to
- Registry conditions: Gastric Cancer (GC), Double-tract Reconstruction, Tubular Gastric Anastomosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Gastroesophageal Reflux and Quality of Life Between Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer Patients
Overview
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
- Procedure Double-tract reconstruction
Patients underwent double-tract reconstruction after radical proximal gastrectomy
Primary outcome measures
- Incidence of postoperative reflux esophagitis [Time frame: 6 month after surgery]
- Severity of reflux esophagitis [Time frame: 6 month after surgery]
Secondary outcome measures (1)
- Postoperative nutritional recovery [Time frame: 1 year after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Publications
- Kim MC, Jung MR, Noh JJ, Kang S, Chung JH, Park JH, Kim TH, Park JK, Kim Y, Seo SH, Kim SE, Kwon OK, Park JY, Park KB, Hwang SH, Lee SH, Lee YJ, Jeong SH, Jeon TY, Kim DH, Choi CI, Yoon KY, Seo KW, Kim KH, Oh SH, Kim KH. Current status of treatment for esophagojejunostomy leakage after total gastrectomy in patients with gastric cancer: a multicenter retrospective study in Korea. J Minim Invasive S PMID 41399049
- Xin C, Wang Z, Zheng Z, Lu S, Wei X, Zhang J, Yin J, Zhang Z. Comparison on the reflux and nutritional status of different reconstruction methods after laparoscopic proximal gastrectomy: a systematic review and network meta-analysis. Updates Surg. 2026 Apr;78(2):575-588. doi: 10.1007/s13304-025-02324-9. Epub 2025 Nov 6. PMID 41196468
- Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available. PMID 32060757
- Zhou J, Li R, Cheng Y, Zhao S, Wang J, Fu Y, Tian Z, Wang L, Wang W, Ren J, Wang D. Comparison of channel esophagogastrostomy and double tract reconstruction after laparoscopic-assisted proximal gastrectomy: a propensity score-matched analysis. Surg Endosc. 2025 Sep;39(9):5722-5732. doi: 10.1007/s00464-025-11978-w. Epub 2025 Jul 17. PMID 40676300
- Tian Z, Cheng Y, Wang Y, Ren J, Wang S, Wang D. 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. Eur J Surg Oncol. 2025 Feb;51(2):109482. doi: 10.1016/j.ejso.2024.109482. Epub 2024 Nov 19. PMID 39580964
- Liu Y, Yan M, Lin Z, Wei S, Li Y, Lin Z, Chen X. Short- and Mid-Term Outcomes of Proximal Gastrectomy With Double-Tract Reconstruction Versus Total Gastrectomy in Early-Stage Proximal Gastric Cancer. Cancer Med. 2025 Sep;14(18):e71258. doi: 10.1002/cam4.71258. PMID 40960020
- Chen CY, Kung CY, Shyr BS, Huang KH, Fang WL, Lin SC, Li AF, Lo SS, Wu CW, Lan YT. Comparison of operative outcomes between proximal and total gastrectomy for proximal gastric cancer. J Chin Med Assoc. 2025 Oct 1;88(10):800-806. doi: 10.1097/JCMA.0000000000001287. Epub 2025 Sep 3. PMID 40898955
Identifiers
NCT: NCT07635836 · KYLL-2026-04-036