Anastomosis, Gastric Cancer, Gastrostomy, Surgery
Conditions
Keywords
Gastric Cancer, Gastrostomy, Billroth II, Braun Anastomosis
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.
Interventions
PROCEDUREBillroth II reconstruction
Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
PROCEDUREBraun 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).
Sponsors
Sichuan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of reflux gastritis assessed according to RGB classification | 6 months, 12 months | by endoscopic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessed by the PGSAS-45 Scale | 6 months, 12 months | The preoperative and postoperative QoL of patients between the two groups. |
| Nutritional status | 6 months, 12 months | Changes in body weight (kg) or BMI from baseline |
| Time to first passage of flatus/stool | within 30 days after surgery | Time taken to pass first stool or flatus |
| Postoperative complications (assessed according to the Clavien-Dindo) | within 30 days after surgery | e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy. |
| Long-term complications | 6 months, 12 months | e.g., food residue and bile reflux (assessed according to the RGB classification). |
Contacts
Primary ContactZhaolun Cai, MD, PhD
Outcome results
None listed