Skip to content

A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)

A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method) - Randomized study for reconstruction after distal gastrctomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000878
Enrollment
320
Registered
2007-11-05
Start date
2005-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Curative distal gastrectomy for gastric cancers

Interventions

Billroth-I method Roux-en-Y method

Sponsors

Clinical surgery research group/The supporting center for clinilcal and education
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Primary treatment for histologically proven adenocarcinoma of the stomach. 2)Indication for distal gastrectomy due to tumor localization 3) Reconstruction feasible for both Billroth I and Roux-en-Y 4) Aged 20 to 90 years old 5) PS (ECOG) of 0 or 16) Curable operation ( Curability B or more according to Japanese Classification for Gastric carcinomas) 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of laparotomy excluding laparoscopic cholecyctectomy and addendectomy (skin incision less than 5cm) 2) Non-curative factors proven by pre-operative examinations 3) Pre-operatiev chemotherapy 4) Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancers 5) Metachronous malignancies within 5 years or with tumor recurrence 6) Severe respiratory dysfunction 7) History of myocardial infarction of two-step Master positive by ECG 8) Liver cirrhosis or chronic active hepatitis 9) Chronic renal failure with hemodialysis 10) Uncontrolled diabetes (HbA1C 9.0 or more) 11) Reflux esophagitis (LA grade A or more) 12) Other unfeasible factors to perform study safely, approved by attending surgeon

Design outcomes

Primary

MeasureTime frame
body weight loss rate at one year afer surgery

Secondary

MeasureTime frame
incidence of delayed gastric empty, reflux esphagitis and surgical complication

Countries

Japan

Contacts

Public ContactYuichiro Doki, MD

Osaka University, Graduate School of Medicine Gastroenterological Surgery

ydoki@surg2.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026