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NCT Number: NCT06511609

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

double-flap technique(DFT); double-tract reconstruction(DTR),

Procedure

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 outcomes

  1. Proportion of patients with reflux esophagitis

    Time frame: Within 12 months after surgery

    The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 12 months after surgery

    Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.

  2. Operation time

    Time frame: Perioperative period

    From the beginning of surgery to the end of surgery

  3. Kamikawa anastomosis time

    Time frame: Perioperative period

    The time of making the seromuscular flap and the time of esophagogastrostomy were included

  4. intraoperative blood loss

    Time frame: Perioperative period

    The operation begins to end the amount of bleeding.

  5. Weight change

    Time frame: Within 12 months after surgery

    Calculated in kilograms

  6. Body Mass Index (BMI)

    Time frame: Within 12 months after surgery

    weight and height will be combined to report BMI in kg/m^2

  7. Albumin value

    Time frame: Within 12 months after surgery

    The concentration of albumin in the blood, expressed in g/L.

  8. Pre albumin value

    Time frame: Within 12 months after surgery

    The concentration of pre albumin in the blood, expressed in g/L.

  9. Hemoglobin value

    Time frame: Within 12 months after surgery

    The concentration of Hemoglobin in the blood, expressed in g/L.

  10. Folic acid value

    Time frame: Within 12 months after surgery

    The concentration of Folic acid value in the blood, expressed in ng/mL.

  11. Vitamin B12 value

    Time frame: Within 12 months after surgery

    The concentration of Vitamin B12 value in the blood, expressed in uug/L.

  12. Ferritin value

    Time frame: Within 12 months after surgery

    The concentration of Vitamin B12 value in the blood, expressed in ug/L.

  13. Nutritional risk screening 2002

    Time frame: Within 12 months after surgery

    The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status.

Study contacts

Contact information is provided by the study sponsor or research team.

WenQing Hu, Dr.

CONTACT

[email protected]

03552066898

Sponsors and collaborators

Lead sponsor

Changzhi People's Hospital Affiliated to Changzhi Medical College

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.