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NCT Number: NCT06229197

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Billroth II reconstruction

Procedure

Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant

Braun Anastomosis

Procedure

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 outcomes

  1. Incidence of reflux gastritis assessed according to RGB classification

    Time frame: 6 months, 12 months

    by endoscopic evaluation

Secondary outcomes

  1. Quality of life assessed by the PGSAS-45 Scale

    Time frame: 6 months, 12 months

    The preoperative and postoperative QoL of patients between the two groups.

  2. Nutritional status

    Time frame: 6 months, 12 months

    Changes in body weight (kg) or BMI from baseline

  3. Time to first passage of flatus/stool

    Time frame: within 30 days after surgery

    Time taken to pass first stool or flatus

  4. Postoperative complications (assessed according to the Clavien-Dindo)

    Time frame: 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.

  5. Long-term complications

    Time frame: 6 months, 12 months

    e.g., food residue and bile reflux (assessed according to the RGB classification).

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaolun Cai, MD, PhD

CONTACT

[email protected]

+86-028-85423610

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Billroth II With Braun Anastomosis Versus Billroth II Anastomosis After Radical Distal Gastrectomy With D2 Lymphadenectomy for Gastric Cancer: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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