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Japanese

Mar. 10, 2026

May. 12, 2026

jRCT1062250098

Clinical trial to evaluate the efficacy and safety of PTFE-coated biliary stents for biliary drainage during neoadjuvant chemotherapy for pancreatic cancer

Clinical trial to evaluate the efficacy and safety of PTFE-coated biliary stents

Matsumoto Kazuyuki

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-7219

matsumoto.k@okayama-u.ac.jp

Matsumi Akihiro

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

+81-86-235-7219

pxbb7o3o@okayama-u.ac.jp

Recruiting

Mar. 10, 2026

April. 23, 2026
40

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients diagnosed with resectable or borderline resectable pancreatic cancer who require biliary drainage.
2. Patients who have received a full explanation of the study, have adequately understood the information provided, and are able to voluntarily provide written informed consent.
3. Patients who are 18 years of age or older at the time of providing informed consent.

1. Patients who are unable to undergo endoscopic procedures.
2. Patients who will not receive preoperative chemotherapy or surgery.
3. Pregnant women or women who may be pregnant.
4. Patients deemed inappropriate for study participation by the principal investigator or sub-investigators.

18age old over
No limit

Both

Resectable or borderline resectable pancreatic cancer requiring biliary drainage

During endoscopic biliary drainage, the stent will be standardized to a PTFE-coated stent group.

Incidence of events (stent occlusion, cholecystitis, pancreatitis)

1. Technical success rate
2. Clinical success rate
3. Adverse event rate

Okayama University Certified Review Board
2-5-1 Shikata-cho, Kita-ku, Okayama city, Okayama

+81-86-235-6503

ouh-crrb@adm.okayama-u.ac.jp
Approval

Jan. 07, 2026

none

History of Changes

No Publication date
2 May. 12, 2026 (this page) Changes
1 Mar. 10, 2026 Detail