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

NCT07635836 | Recruiting DMC

• 1 other identifier: KYLL-2026-04-036
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative reflux esophagitis

  The diagnosis of reflux esophagitis was based on symptoms, endoscopic findings, and 24-hour esophageal pH monitoring.

  6 month after surgery

• 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).

  6 month after surgery

Secondary Outcomes (1)

• Postoperative nutritional recovery

  1 year after surgery

Study Arms (2)

DTR Group

EXPERIMENTAL

Patients in this group underwent radical proximal gastrectomy with double-tract reconstruction.

Procedure: Double-tract reconstruction

TGA Group

NO INTERVENTION

Patients in this group underwent radical proximal gastrectomy with tubular gastric anastomosis.

Interventions

Double-tract reconstruction PROCEDURE

Patients underwent double-tract reconstruction after radical proximal gastrectomy

DTR Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (7)

• 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 Surg. 2025 Dec 15;28(4):184-192. doi: 10.7602/jmis.2025.28.4.184.

  PMID: 41399049 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Hui Qu, Doctor of Medicine

CONTACT

+8618560085120; doctorquhui@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)