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

NCT ID: NCT06229197

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-12-31

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.

Conditions

Gastric Cancer; Surgery; Anastomosis; Gastrostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Billroth II with Braun Reconstruction

Group Type: EXPERIMENTAL

Billroth II reconstruction

Intervention Type: PROCEDURE

Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant

Braun Anastomosis

Intervention Type: PROCEDURE

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).

Billroth II Reconstruction

Group Type: ACTIVE_COMPARATOR

Billroth II reconstruction

Intervention Type: PROCEDURE

Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant

Interventions

Billroth II reconstruction

Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Bo Zhang, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Zhang, MD

Role: STUDY_CHAIR

Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University

Zhaolun Cai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University

Central Contacts

Zhaolun Cai, MD, PhD

Role: CONTACT

caizhaolun@foxmail.com

+86-028-85423610

Other Identifiers

2023HXFH005

Identifier Type: -

Identifier Source: org_study_id