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

Sichuan University

Status: Not yet enrolling

Conditions: Gastric Cancer; Surgery; Anastomosis; Gastrostomy

Treatments: Procedure: Billroth II reconstruction; Procedure: Braun Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06229197

2023HXFH005

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Billroth II with Braun Reconstruction

Experimental group

Treatment:

Procedure: Billroth II reconstruction

Procedure: Braun Anastomosis

Billroth II Reconstruction

Active Comparator group

Treatment:

Procedure: Billroth II reconstruction