Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer

Not Applicable

Not yet recruiting

• Conditions: Anastomosis; Gastric Cancer; Surgery; Gastrostomy
• Interventions: Procedure: Billroth II reconstruction; Procedure: Braun Anastomosis

• Registration Number: NCT06229197
• Lead Sponsor: Sichuan University

Brief Summary

The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Billroth II with Braun Reconstruction	Billroth II reconstruction	-
Billroth II Reconstruction	Billroth II reconstruction	-
Billroth II with Braun Reconstruction	Braun Anastomosis	-

Primary Outcome Measures

Name	Time	Method
Incidence of reflux gastritis assessed according to RGB classification	6 months, 12 months	by endoscopic evaluation

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by the PGSAS-45 Scale	6 months, 12 months	The preoperative and postoperative QoL of patients between the two groups.
Nutritional status	6 months, 12 months	Changes in body weight (kg) or BMI from baseline
Time to first passage of flatus/stool	within 30 days after surgery	Time taken to pass first stool or flatus
Postoperative complications (assessed according to the Clavien-Dindo)	within 30 days after surgery	e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy.
Long-term complications	6 months, 12 months	e.g., food residue and bile reflux (assessed according to the RGB classification).