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Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract

Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract - Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041597
Enrollment
60
Registered
2020-08-28
Start date
2020-09-01
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

pancreatic cancer with unresectable malignant obstruction of the distal biliary tract

Interventions

12mm-diameter stent placement 10mm-diameter stent placement

Sponsors

Fujita Health University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Cases with jaundice or hepatic dysfunction. Jaundice has a serum total bilirubin level of 3.0 mg/dl or more, and liver dysfunction is blood transaminase, ALP, or GTP. (2) Patients with malignant histopathological confirmation. (3)Unresectable is confirmed by diagnostic imaging or patient background factors. (4)Expanded bile duct diameter is 12 mm or more by image diagnosis when confirming obstructive jaundice or liver function abnormality (5)Biliary stricture exists in the middle and lower parts that do not reach the hilum of the liver (6)Patients with ECOG Performance Status 0 or 1. (7)Expected survival time of 4 months or more (8)The age at the time of obtaining consent is 20 or more and less than 80.

Exclusion criteria

Exclusion criteria: (1) Reconstruction methods other than Billoth-I reconstruction are used after gastrectomy. (2) Patients with obstruction of the anus from the duodenal papilla. (3) Patients who had a metal stent in the past. (4) Cases with serious complications in other organs (ASA classification 3 or higher.) (5) Patients with acute pancreatitis and acute exacerbation of chronic pancreatitis. (6) Patients with cirrhosis (Child-Pugh Grade B or C) (7) Platelet count is 50,000/mm3 or less according to the latest test value within 28 days before registration. (8) In addition, patients who are judged by the attending physician to be inappropriate for conducting this study.

Design outcomes

Primary

MeasureTime frame
The patency of the 12mm-diameter metal stent.

Countries

Japan

Contacts

Public ContactKazunori Nakaoka

Fujita Health University Department of Gastroenterology and Gastroenterological Oncology

knakaoka@fujita-hu.ac.jp+81-562-93-2324

Outcome results

None listed

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