Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study

Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study - Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025463

Enrollment

Registered

2017-01-30

Start date

2017-01-01

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

Resectable malignant hilar biliary obstruction

Interventions

In undrainage patients, the site of biliary structure was confirmed endoscopically and naso-biliary drainage (ENBD) was performed firstly. After relieve of jaundice, ENBD was exchanged for inside-sten

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Resectable biliary tract cancer (intrahepatic, perihilar, or distal cholangiocarcinoma, gallbladder carcinoma) with obstructive jaundice 2. Life expectancy > 3 months 3. Endoscopic preoperative biliary drainage or radical surgery can be performed safely. 4. Endoscopic cholangiography shows the distance from the stricture to the sphincter of Oddi is at least 3cm. 5. Patients of age >= 20 years 6. ECOG performance status of 0-2 7. ASA calassification of 0-2 8. Adequate organ function 9. Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1. History of radiotherapy, chemotherapy or immunotherapy for malignant disease before starting the study treatment 2. Preoperative biliary drainage is not needed. 3. PTBD has been performed at previous hospital. 4. Severe complications such as intestinal pneumonia, pulmonary fibrosis, and heart failure 5. Psychosis or severe mental disorder 6. Pregnant or lactating female and patients who is considering pregnancy 7. Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Time to recurrent biliary obstruction of inside-sten	—

Secondary

Measure	Time frame
1. Overall number of re-intervention after initial biliary drainage 2. Success rate and complication rate of inside-stent placement 3. Recurrent biliary obstruction rate of inside-stent 4. Overall morbidity and infectious complication rate after surgery	—

Countries

Japan

Contacts

Public ContactYu Takahashi

Japanese foundation for cancer research, Cancer institute hospital Department of Gastroenterological Surgery

yu.takahashi@jfcr.or.jp+81-3-3520-0111

Outcome results

None listed

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