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Single vs Double internal biliary stents in treating difficult common bile duct stone: Thailand multi-center randomized controlled trial.

Single vs Double internal biliary stents in treating difficult common bile duct stone: Thailand multi-center randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180713002
Enrollment
126
Registered
2018-07-13
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Difficult common bile duct stone (large in size and numbers) Difficult common bile duct stone Internal biliary stent

Interventions

After difficult common bile duct stone detected&#44
a 7Fr&#44
double pigtailed&#44
7 cm plastic stent will be inserted&#44
cross the stone&#44
into proximal bile duct. ,After difficult common bile duct stone detected&#44
"two" 7Fr&#44
into proximal bile duct.
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery
Single stent ,Double stent

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. CBD stone: Size ≥ 13 - 15 mm and/ or Number ≥3 and the endoscopist decides that may increase risk to patients. 2. Cannot be removed by conventional endoscopic technique (balloon and/or basket extraction, mechanical lithotripsy, major EST and trans-papillary large balloon dilatation. 3. Choose to be treated by 2nd ERCP session (rather than surgery) or unfitted for surgery.

Exclusion criteria

Exclusion criteria: 1. Toxic cholangitis or Grade III (severe) acute cholangitis (Tokyo Guideline) 2. Has been treated with surgical and/or endoscopic treatment on biliary tract.

Design outcomes

Primary

MeasureTime frame
CBD stone size 3 to 6 months after stent insertion Size = Measured diameter of the stone x (Actual diameter of the duodenoscope/ Mesured diameter),CBD stone numbers 3 to 6 months after stent insertion Count from cholangiography,Successful bile duct clearance with conventional endoscopic technique 3 to 6 months after stent insertion All stones area cleared

Secondary

MeasureTime frame
ERCP related complication 1 month after ERCP Post -procedural record ,2. Stent related complication: Migration, Occlusion within 3 to 6 month (interval between the first and second ERC) LFT and plain film

Countries

Thailand

Contacts

Public ContactSuppadech Tunruttanakul

Unaffiliated

sdtaaa@yahoo.com+66897590770

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026