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A randomized controlled clinical study comparing the efficacy of laparoscopic radical gastrectomy with Billroth II anastomosis and Billroth II +Braun anastomosis

A randomized controlled clinical study comparing the efficacy of laparoscopic radical gastrectomy with Billroth II anastomosis and Billroth II +Braun anastomosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097545
Enrollment
Unknown
Registered
2025-02-20
Start date
2024-01-31
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Experimental group:Billroth II+Braun anastomosis
Control group:Billroth II anastomosis

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75, either male or female; 2. Gastric adenocarcinoma was confirmed by pathology; 3. The tumor was located in the middle and lower part of the stomach (the distance between the proximal end of the tumor and the cardiac was >5cm). 4. Laparoscopic radical distal gastrectomy, including laparoscopically assisted or total abdominal surgery, is expected to be performed; 5. The preoperative clinical stage was cT1-4aN0-3M0, or the clinical stage was ycT1-4aN0-3M0 after neoadjuvant therapy; 6. ECOG physical strength score 0 or 1 before operation; 7. Preoperative ASA score was I-III; 8. Be able to complete the EORTC questionnaire.

Exclusion criteria

Exclusion criteria: 1. There are clear anesthesia or surgical contraindications; 2. Gastric stump cancer or a history of gastric surgery; 3. There is insufficiency of critical organs, which cannot tolerate surgery; 4. Advanced tumor, surgery for palliative purpose; 5. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; 6. Robotic platform surgery or open surgery; 7. Concurrent or previous history of other malignant tumors; 8. Pregnant or lactating women; 9. Those who suffer from mental illness and cannot cooperate with treatment; 10. History of unstable angina pectoris or myocardial infarction within 6 months; 11. History of cerebral infarction or cerebral hemorrhage within 6 months; 12. A history of continuous systemic corticosteroid therapy within 1 month; 13. Concurrent surgical treatment for other diseases is required; 14. Those who refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Quality of Life Questionnaire (QLQ-STO22) score for patients with gastric cancer;

Secondary

MeasureTime frame
Incidence of reflux gastritis;Intraoperative blood loss;Total operation time;The time length of digestive tract reconstruction;Post-operative hospital stay;Hospitalization expenses;Incidence of anastomotic leakage;Incidence of anastomotic bleeding;Incidence of bowel obstruction;Incidence of duodenal stump leakage;Hemoglobin level;Serum total protein level;Serum albumin level;Body mass index;

Countries

China

Contacts

Public ContactXin Zhang

Shanghai Changzheng Hospital

czzx86@163.com+86 139 1651 1579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026