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

NCT06511609 | Not Yet Recruiting

• 1 other identifier: CZPH-0001
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Proximal Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with reflux esophagitis

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

  Within 12 months after surgery

Secondary Outcomes (13)

• Postoperative complications

  Within 12 months after surgery

• Operation time

  Perioperative period

• Kamikawa anastomosis time

  Perioperative period

• intraoperative blood loss

  Perioperative period

• Weight change

  Within 12 months after surgery

Study Arms (2)

double-flap technique（DFT）

EXPERIMENTAL

Laparoscopic proximal gastrectomy with double flap anastomosis group

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

double-tract reconstruction（DTR）

ACTIVE COMPARATOR

Laparoscopic proximal gastrectomy with double-tract anastomosis group

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

Interventions

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.

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changzhi People's Hospital Affiliated to Changzhi Medical College: lead

Study Officials

• WenQing Hu

  502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China

  STUDY CHAIR

Central Study Contacts

WenQing Hu, Dr.

CONTACT

03552066898; beibeihejiyy@163.com

Study Design

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 22, 2024

Record last verified: 2024-05