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NCT06511609Not yet recruiting

The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.

Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.

Source: ClinicalTrials.gov · Last updated 22 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
244 (estimated)
First submitted
8 Jul 2024
Start date
1 Aug 2024
Primary completion date
31 Jul 2026
Lead sponsor
Changzhi People's Hospital Affiliated to Changzhi Medical College
NCT number
NCT06511609

What you commit to

  • Study type: Interventional
  • Planned participants: 244
  • From 1 Aug 2024 to the primary completion date, 31 Jul 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
  • Presence of contraindications to surgery;
  • Previous upper abdominal surgery (excluding cholecystectomy);
  • Patients who have received or are currently receiving treatment for systemic inflammatory diseases;

Other illness

  • Multiple malignant lesions in the stomach;
  • Presence of other malignancies that may affect the preservation of stomach function;
  • Preoperative examination reveals active peptic ulcer;
  • Conditions deemed unsuitable for participation in this study by the investigator.

Other

  • Pregnant or breastfeeding women;

Who the study is looking for

  • Age between 20 and 80 years, regardless of gender;
  • Patients diagnosed with gastric cancer through tissue biopsy;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • American Society of Anesthesiologists (ASA) classification of I to III;
  • Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:
    • Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
  • Voluntary signing of informed consent.

Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.