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

Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Surgery; Gastrostomy; Anastomosis
• Intervention / Treatment: Procedure: Billroth II reconstruction; Procedure: Braun Anastomosis

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaolun Cai, MD, PhD; Phone Number: +86-028-85423610; Email: caizhaolun@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:

1. Histologically proven stage I-III gastric cancer, evaluated as radically resectable
2. No synchronous or metachronous cancers
3. Patients have signed informed consent forms
4. Age 18-80 years old
5. No malfunction of cardio-pulmonary, liver, and kidney, ECOG score 0-1
6. No emergency surgery needed

Exclusion criteria

Patients will be excluded according to the following criteria:

1. Pregnant or lactating women
2. Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination
3. Ascites or cachexia
4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
5. Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
6. Mental illness
7. Surgical history whose influence has not been eliminated
8. History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid
9. Active infection with a fever of over 38°C
10. Poor compliance
11. Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Billroth II with Braun Reconstruction	Procedure: Billroth II reconstruction; Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant; Procedure: Braun Anastomosis; This is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure).
Active Comparator: Billroth II Reconstruction	Procedure: Billroth II reconstruction; Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reflux gastritis assessed according to RGB classification	by endoscopic evaluation	6 months, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sichuan University
• Investigators: Study Chair: Bo Zhang, MD, Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University; Principal Investigator: Zhaolun Cai, MD, PhD, Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Gastric Cancer; Gastrostomy; Billroth II; Braun Anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2023HXFH005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No