Menu
Not yet recruiting NCT06511609

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

No phase Interventional Proximal Early 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-flap technique（DFT）; double-tract reconstruction(DTR),.
Who it may be relevant to
Registry conditions: Proximal Early Gastric Cancer. Basic parameters: 20 years — 80 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
Center list to be confirmed — check the primary protocol.
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 Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.

Overview

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.

Detailed description

This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.

Interventions

  • Procedure double-flap technique（DFT）; double-tract reconstruction(DTR),
    DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.

Primary outcome measures

  • Proportion of patients with reflux esophagitis [Time frame: Within 12 months after surgery]
Secondary outcome measures (12)
  • Postoperative complications [Time frame: Within 12 months after surgery]
  • Operation time [Time frame: Perioperative period]
  • Kamikawa anastomosis time [Time frame: Perioperative period]
  • intraoperative blood loss [Time frame: Perioperative period]
  • Weight change [Time frame: Within 12 months after surgery]
  • Body Mass Index (BMI) [Time frame: Within 12 months after surgery]
  • Albumin value [Time frame: Within 12 months after surgery]
  • Pre albumin value [Time frame: Within 12 months after surgery]
  • Hemoglobin value [Time frame: Within 12 months after surgery]
  • Folic acid value [Time frame: Within 12 months after surgery]
  • Vitamin B12 value [Time frame: Within 12 months after surgery]
  • Ferritin value [Time frame: Within 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
  • Presence of contraindications to surgery;
  • Multiple malignant lesions in the stomach;
  • Presence of other malignancies that may affect the preservation of stomach function;
  • Previous upper abdominal surgery (excluding cholecystectomy);
  • Preoperative examination reveals active peptic ulcer;
  • Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
  • Pregnant or breastfeeding women;
  • Conditions deemed unsuitable for participation in this study by the investigator.

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
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06511609 · CZPH-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗