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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChangzhi People's Hospital Affiliated to Changzhi Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: double-flap technique(DFT)Experimental treatment 1 intervention
Group B: double-tract reconstruction(DTR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with reflux esophagitis

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

Time frame
Within 12 months after surgery

Secondary outcomes

1

Postoperative complications

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

Time frame
Within 12 months after surgery
2

Operation time

From the beginning of surgery to the end of surgery

Time frame
Perioperative period
3

Kamikawa anastomosis time

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

Time frame
Perioperative period
4

intraoperative blood loss

The operation begins to end the amount of bleeding.

Time frame
Perioperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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