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Gastric Cancer (GC)NCT07635836

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

A study testing Double-tract reconstruction in people with Gastric Cancer (GC) and Double-tract Reconstruction, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Double-tract reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 May 2026to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Qu, Doctor of Medicine contact

+8618560085120

doctorquhui@email.sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

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

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Double-tract reconstruction
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double-tract reconstructionProcedure or surgery

    Patients underwent double-tract reconstruction after radical proximal gastrectomy

Study groups in NCT07635836
Study groupRoleWhat they receive
DTR GroupExperimentalPatients in this group underwent radical proximal gastrectomy with double-tract reconstruction.
Receives: Procedure: Double-tract reconstruction
TGA GroupNo interventionPatients in this group underwent radical proximal gastrectomy with tubular gastric anastomosis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative reflux esophagitis

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

    Measured: 6 month after surgery

  2. 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).

    Measured: 6 month after surgery

Secondary outcomes (1)

  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.

    Measured: 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 May 2026
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635836
Sponsor's protocol ID
KYLL-2026-04-036
Status last verified
Apr 2026
First submitted
3 Jun 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40898955

Questions about this trial

What is this clinical trial studying?

A study testing Double-tract reconstruction in people with Gastric Cancer (GC) and Double-tract Reconstruction, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Qu, Doctor of Medicine (+8618560085120, doctorquhui@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative reflux esophagitis (time frame: 6 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635836, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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