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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229197
• Other study ID #: 2023HXFH005
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Sichuan University
• Contact: Zhaolun Cai, MD, PhD
• Phone: +86-028-85423610
• Email: caizhaolun[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomosis
• Gastric Cancer
• Gastrostomy
• Stomach Neoplasms
• Surgery

Intervention

Procedure:
• Billroth II reconstruction
Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of reflux gastritis assessed according to RGB classification	by endoscopic evaluation	6 months, 12 months
Secondary	Quality of life assessed by the PGSAS-45 Scale	The preoperative and postoperative QoL of patients between the two groups.	6 months, 12 months
Secondary	Nutritional status	Changes in body weight (kg) or BMI from baseline	6 months, 12 months
Secondary	Time to first passage of flatus/stool	Time taken to pass first stool or flatus	within 30 days after surgery
Secondary	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
Secondary	Long-term complications	e.g., food residue and bile reflux (assessed according to the RGB classification).	6 months, 12 months