Surgery 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sichuan University |
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 |
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