NCT06062225

Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Single-Tract Jejunal Interposition Versus SOFY Reconstruction) After Proximal Gastrectomy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.

Detailed description

In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.

Conditions

• Proximal Gastric Adenocarcinoma
• Gastrectomy
• Anastomosis
• Reflux Esophagitis
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Kamikawa	Kamikawa reconstruction after proximal gastrectomy
PROCEDURE	STJI	Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy
PROCEDURE	SOFY	SOFY reconstruction after proximal gastrectomy

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-12-01
• Completion: 2026-10-01
• First posted: 2023-10-02
• Last updated: 2023-10-05