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NCT Number: NCT05344339

Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy.

Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location status: Recruiting

Location contact

L D.

CONTACT

Long D. Vo, MD.

CONTACT

[email protected]

+84918133915

About this study

Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial.

At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients confirmed with gastric cancer
  • Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
  • Age from 18- to 80-year-old
  • Agreed to participate in study with written inform consent

Exclusion criteria

  • Pregnant patients
  • An American Society of Anesthesiology (ASA) score of higher than 4
  • Concurrent cancer or history of previous other cancers
  • Previous gastrectomy
  • Complications including bleeding, perforation required emergency gastrectomy

Treatment and study plan

Distal gastrectomy

Procedure

Reconstruction after Distal Gastrectomy

Primary outcomes

  1. Reflux esophagistis

    Time frame: on the 12th month after surgery

    Findings of reflux esophagitis according to Los Angeles classification via endoscopy

Secondary outcomes

  1. Early complications

    Time frame: 30 days after surgery

    Rate of any complications happened intraoperative and 30-days post-operative

  2. Operative time

    Time frame: Intraoperative

    Time from first incision to finishing abdomen closure, measured by surgical nurse

  3. Time for making anastomosis

    Time frame: Intraoperative

    Time from jejunal stapler opening (for B-II) or from jejunal separating (for R-II) to finishing enhancing suture (including duodenal stump enhancement)

  4. Blood loss

    Time frame: Intraoperative

    Weighing of sucked blood and gauze, minus weighing of dry gauze

  5. Length of post-operative hospital stay

    Time frame: 30 days after surgery or until mortality

    Number of days from date of surgery until date of discharge or mortality

  6. Post gastrectomy syndromes

    Time frame: from 30 days to 1 years after surgery

    Rate of post gastrectomy syndromes after gastrectomy

  7. Bodyweight

    Time frame: on the 3rd, 6th, and 12th month after surgery

    Changing of patient's weight at the follow-up time compare to weight before surgery

  8. Serum total protein

    Time frame: on the 3rd, 6th, and 12th month after surgery

    Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery

  9. Serum albumin

    Time frame: on the 3rd, 6th, and 12th month after surgery

    Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery

  10. Hemoglobin

    Time frame: on the 3rd, 6th, and 12th month after surgery

    Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery

  11. Changing of Gastric remnant gastritis

    Time frame: on the 6th, and 12th month after surgery

    Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)

  12. Changing of Residual food

    Time frame: on the 6th, and 12th month after surgery

    Grade of Residual food according to RGB classification via endoscopy

  13. Changing of bile reflux

    Time frame: on the 6th, and 12th month after surgery

    Finding of bile reflux according to RGB classification via endoscopy

  14. Changing of GSRS score

    Time frame: on the 3rd, 6th, and 12th month after surgery

    Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire

  15. 6th month reflux esophagistis

    Time frame: on the 6th month after surgery

    Findings of reflux esophagitis according to Los Angeles classification via endoscopy

Study contacts

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

Long D. Vo, MD PhD

CONTACT

[email protected]

+84918133915

Thong Q. Dang, MD, MSc

CONTACT

[email protected]

+84333997861

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2022
Registry last updated
Jan 1, 2025

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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