Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant or lactating women
Distant metastasis to the liver, lung, bone, supraclavicular lymph nodes, pelvic, or ovarian species and peritoneal dissemination
Ascites or cachexia
Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Billroth II reconstruction
Procedure/SurgeryBillroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
Braun Anastomosis
Procedure/SurgeryThis 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).
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Billroth II with Braun ReconstructionExperimental treatment 2 interventions
Group B: Billroth II ReconstructionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of reflux gastritis assessed according to RGB classification
by endoscopic evaluation
Time frame
6 months, 12 monthsSecondary outcomes
1
Quality of life assessed by the PGSAS-45 Scale
The preoperative and postoperative QoL of patients between the two groups.
Time frame
6 months, 12 months2
Nutritional status
Changes in body weight (kg) or BMI from baseline
Time frame
6 months, 12 months3
Time to first passage of flatus/stool
Time taken to pass first stool or flatus
Time frame
within 30 days after surgery4
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.
Time frame
within 30 days after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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