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

NCT06229197 | Not Yet Recruiting

• 1 other identifier: 2023HXFH005
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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

Keywords

Gastric Cancer; Gastrostomy; Billroth II; Braun Anastomosis

Outcome Measures

Primary Outcomes (1)

• Incidence of reflux gastritis assessed according to RGB classification

  by endoscopic evaluation

  6 months, 12 months

Secondary Outcomes (5)

• Quality of life assessed by the PGSAS-45 Scale

  6 months, 12 months

• Nutritional status

  6 months, 12 months

• Time to first passage of flatus/stool

  within 30 days after surgery

• Postoperative complications (assessed according to the Clavien-Dindo)

  within 30 days after surgery

• Long-term complications

  6 months, 12 months

Study Arms (2)

Billroth II with Braun Reconstruction

EXPERIMENTAL

Procedure: Billroth II reconstruction; Procedure: Braun Anastomosis

Billroth II Reconstruction

ACTIVE COMPARATOR

Procedure: Billroth II reconstruction

Interventions

Billroth II reconstruction PROCEDURE

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

Billroth II Reconstruction; Billroth II with Braun Reconstruction

Braun Anastomosis 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 with Braun Reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Bo Zhang, MD

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

  STUDY CHAIR

• Zhaolun Cai, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaolun Cai, MD, PhD

CONTACT

+86-028-85423610; caizhaolun@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2024

Record last verified: 2024-01