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Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy

Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy - Progress 12 Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054798
Enrollment
50
Registered
2024-08-01
Start date
2024-08-01
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

pancreatic cancer

Interventions

Endoscopic transpapillary biliary drainage using 12-Fr plastic stent.

Sponsors

Sendai City Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Those who have been diagnosed as resectable or borderline resectable pancreatic cancer by blood test, imaging or histology. b. Those who need biliary drainage* before preoperative chemotherapy * Total bilirubin =/> 2.0mg/dL or AST =/> 100U/L. c. Those who are planned to receive preoperative chemotherapy after biliary drainage. d. No history of previous biliary stent placement. e. Obtaining written informed consent

Exclusion criteria

Exclusion criteria: a. No tolerance of endoscopic procedures b. ASA class 4 or more c. Post-gastrectomy reconstruction using methods other than Billroth I d. Not intended to receive preoperative chemotherapy e. History of percutaneous transhepatic biliary drainage or endoscopic ultrasound-guided biliary drainage f. Duodenal stenosis is suspected on specific symptoms or imaging studies g. Age < 18 years h. Already enrolled in this clinical trial i. Allergic for contrast j. Pregnancy k. Difficult to follow up l. Judged to be ineligible by investigators

Design outcomes

Primary

MeasureTime frame
recurrent biliary obstruction (RBO) rate in the observation period observation period: from the date of biliary drainage to the earliest date of surgery, the decision not to resect pancreatic cancer, or 1 year after biliary drainage.

Secondary

MeasureTime frame
technical success rate, clinical success rate, rate of adverse events related to endoscopic procedures, time to surgical operation, time to recurrent biliary obstruction (TRBO).

Countries

Japan

Contacts

Public ContactHidehito Sumiya

Sendai City Medical Center Department of Gastroenterology

hsumiya@openhp.or.jp022-252-1111

Outcome results

None listed

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