Suprapapillary versus Transpapillary Plastic Stenting for Preoperative Drainage in Hilar Obstruction: A Randomized Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260516003

Enrollment

Registered

2026-05-16

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with benign and malignant hilar biliary obstructions (resectable or borderline resectable) who indicated for preoperative biliary drainage suprapapillary stent hilar obstruction preoperative biliary drainage recurrent biliary obstruction

Interventions

Endoscopic drainage with placing plastic stent(s) above the papilla,Endoscopic drainage with placing plastic stent(s) across the papilla

Experimental Device,Active Comparator Device

Suprapapillary plastic stenting ,Transpapillary plastic stenting

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 80 years old 2. Benign and malignant hilar biliary obstructions e.g. cholangiocarcinoma, gallbladder cancer, hepatocellular carcinoma, hilar lymph node invasion, postoperative biliary strictures, primary sclerosing cholangitis, IgG4 related cholangitis, IHD stones with strictures 3. Evidence of hilar stricture from cross sectional imaging (CT or MRI) or endoscopic findings compatible with Bismuth-Corlette classification I, II or III 4. Indicated for preoperative biliary drainage e.g. total bilirubin greater than 2 mg per dL, predicted future liver remnant less than 30 percent or delayed surgery 5. In cases of malignant hilar biliary obstruction evaluated as resectable or borderline resectable

Exclusion criteria

Exclusion criteria: 1. Acute cholangitis according to the Tokyo Guidelines 2018 2. Previous PTBD insertion 3. Previous placement of a biliary stent 4. Condition that total bilirubin elevation would cause difficulty in evaluation of clinical efficacy of the primary intervention e.g., decompensated liver disease, active hemolytic diseases 5. Surgically altered anatomy excepts Billroth-I gastroduodenostomy 6. High endoscopic risks 7. Pregnancy

Design outcomes

Primary

Measure	Time frame
Rate of recurrent biliary obstruction 60 days Stent occlusion or stent migration, assessed by laboratory and/or imaging	—

Secondary

Measure	Time frame
Technical success Immediately after procedure Successful stent placement at indicated bile duct,Clinical success 2 weeks total bilirubin levels decrease great than 50% or normalization	—

Countries

Thailand

Contacts

Public ContactNontalee Pausawasdi

Department of Medicine

nonthaleep7@gmail.com66892351515

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026