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Not yet recruiting NCT06229197

Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer

No phase Interventional Gastric Cancer Surgery Anastomosis Gastrostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Billroth II reconstruction, Braun Anastomosis.
Who it may be relevant to
Registry conditions: Gastric Cancer, Surgery, Anastomosis, Gastrostomy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Procedure Billroth II reconstruction
    Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
  • Procedure Braun 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).

Primary outcome measures

  • Incidence of reflux gastritis assessed according to RGB classification [Time frame: 6 months, 12 months]
Secondary outcome measures (5)
  • Quality of life assessed by the PGSAS-45 Scale [Time frame: 6 months, 12 months]
  • Nutritional status [Time frame: 6 months, 12 months]
  • Time to first passage of flatus/stool [Time frame: within 30 days after surgery]
  • Postoperative complications (assessed according to the Clavien-Dindo) [Time frame: within 30 days after surgery]
  • Long-term complications [Time frame: 6 months, 12 months]

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:

  • 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

Exclusion criteria

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
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension or diabetes
  • Participation in other clinical trials 4 weeks before the enrollment of this trial or still participating in other trials
  • Mental illness
  • Surgical history whose influence has not been eliminated
  • History of another gastric or esophageal malignancy, including stromal tumor, sarcoma, lymphoma, and carcinoid
  • Active infection with a fever of over 38°C
  • Poor compliance
  • Not suitable for this trial because of other clinical or laboratory conditions determined by the researchers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06229197 · 2023HXFH005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗