JRCT ID: jRCT1062250098
Registered date:10/03/2026
Clinical trial to evaluate the efficacy and safety of PTFE-coated biliary stents
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Resectable or borderline resectable pancreatic cancer requiring biliary drainage |
| Date of first enrollment | 23/04/2026 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | During endoscopic biliary drainage, the stent will be standardized to a PTFE-coated stent group. |
Outcome(s)
| Primary Outcome | Incidence of events (stent occlusion, cholecystitis, pancreatitis) |
|---|---|
| Secondary Outcome | 1. Technical success rate 2. Clinical success rate 3. Adverse event rate |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 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. |
| Exclude criteria | 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. |
Related Information
| Primary Sponsor | Matsumoto Kazuyuki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Akihiro Matsumi |
| Address | 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558 |
| Telephone | +81-86-235-7219 |
| pxbb7o3o@okayama-u.ac.jp | |
| Affiliation | Okayama University Hospital |
| Scientific contact | |
| Name | Kazuyuki Matsumoto |
| Address | 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558 |
| Telephone | +81-86-235-7219 |
| matsumoto.k@okayama-u.ac.jp | |
| Affiliation | Okayama University Hospital |