NCT06229197Not yet recruiting
Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer
Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 1 Jan 2024
- Start date
- Feb 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Sichuan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06229197
What you commit to
- Study type: Interventional
- Planned participants: 176
- From Feb 2024 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
- Surgical history whose influence has not been eliminated
Other illness
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
- Mental illness
- History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid
- Active infection with a fever of over 38°C
Lab values
- Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers
Other
- 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
- Poor compliance
Who the study is looking for
- To be enrolled, participants must be phase I-III patients with initial treatment of radical distal gastrectomy and satisfying the following inclusion criteria:
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.