Clinical trial NCT06229197: Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Surgery
Anastomosis
Gastrostomy
Keywords: Gastric Cancer
Gastrostomy
Billroth II
Braun Anastomosis
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of reflux gastritis assessed according to RGB classification
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Quality of life assessed by the PGSAS-45 Scale
timeFrame: 6 months, 12 months
measure: Nutritional status
timeFrame: 6 months, 12 months
measure: Time to first passage of flatus/stool
timeFrame: within 30 days after surgery
measure: Postoperative complications (assessed according to the Clavien-Dindo)
timeFrame: within 30 days after surgery
measure: Long-term complications
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University
name: Bo Zhang, MD
role: STUDY_CHAIR
affiliation: Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University
name: Zhaolun Cai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: