Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy

Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy - Roux-en-Y anastomosis of the pancreatic stump following distal pancreatectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005722

Enrollment

136

Registered

2011-06-06

Start date

2011-06-01

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

disease of pancreatic body and tail

Interventions

Roux-en-Y anastomosis of the pancreatic stump following distal pancreatectomy Stapling closure of the pancreatic stump following distal pancreatectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) disease of pancreatic body and tail 2) PS (ECOG Performance Status Scale):0-1 3) Age: 20 years or older 4) distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis. 5) Adequate organ functions filled the following criteria within two weeks from enrollment: 1.White blood cell more than 3,500/mm3 or less than 12,000/mm3 2.Neutrophilic leukocyte more than 2,000/mm3 3.Platelet more than 100,000/mm3 4.Hemoglobin more than 9.0g/dL 5.Total bilirubin less than 2.0mg/dL 6.AST and ALT less than 150IU/L 7.Creatinine less than 1.5mg/dL 6)Patients who can provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with severe liver cirrhosis or active hepatitis 2. Patients with respiratory illness that requires oxygen administration 3. .Patients with chronic renal failure requiring dialysis 4. Patients with active duplicative malignant disease affecting adverse event 5. Others, patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
Incidence of pancreatic fistula defined by ISGPF	—

Secondary

Measure	Time frame
1) morbidity 2) mortality 3) postoperative hospital stay 4) new onset or worsening diabetes 5) nutritional status 6) quality of life 7) Incidence of pancreatic fistula grade B/C 8) Incidence of pancreatic fistula grade C 9) Incidence of intraabdominal bleeding 10) Incidence of pancreatic fistula based on thickness of the pancreas	—

Countries

Japan

Contacts

Public ContactManabu Kawai

Wakayama Medical University, School of Medicine Second Department of Surgery

kawai@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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