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

ConditionsGastric CancerDistal Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant patients

An American Society of Anesthesiology (ASA) score of higher than 4

Concurrent cancer or history of previous other cancers

Previous gastrectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Distal gastrectomy

    Procedure/Surgery

    Reconstruction after Distal Gastrectomy

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Billroth-II modifiedExperimental treatment 1 intervention
Group B: Roux-en-YActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reflux esophagistis

Findings of reflux esophagitis according to Los Angeles classification via endoscopy

Time frame
on the 12th month after surgery

Secondary outcomes

1

Early complications

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

Time frame
30 days after surgery
2

Operative time

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

Time frame
Intraoperative
3

Time for making anastomosis

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

Time frame
Intraoperative
4

Blood loss

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

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Ho Chi Minh City (UMC)

Lead sponsor

Source ClinicalTrials.gov
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