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Treatment of bile duct stones of difficult removal compared two endoscopic methods: Stone fragmentation with electrohydraulic lithotripsy (EHL) X balloon dilation of the major duodenal papilla

Endoscopic treatment of bile duct stones of difficult removal compared two methods: Use of Direct Visualization System of Bile Ducts ("Spyglass Direct Visualization System") associated with electrohydraulic lithotripsy (EHL) X hydrostatic balloon dilation of the major duodenal papilla followed by scanning extractor balloon

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5wx47j
Enrollment
Unknown
Registered
2016-09-05
Start date
2014-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Digestive system diseases. Choledocholithiasis

Interventions

100 patients will be allocated into 2 groups after the diagnosis of bile ducts stones considered difficult to remove. In group 1 patients will undergo an endoscopic sphincterotomy which is the surgica
Procedure/surgery
E01.370.350.700.715.200
E02.600
C06.130.120.250.174
E04.210.120.850
E05.284

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years and both genders (male and female). Capable of consent, agreed and signed the Term of Consent. Bile duct stones considered difficult to remove. Biliary stones in bile ducts

Exclusion criteria

Exclusion criteria: Age below 18 years. Incapable of giving consent. Pregnant. Gastrointestinal bypass surgery with previous reconstructions as Billroth II or Roux-en-Y. Patients with signs of severe acute cholangitis requiring biliary drainage with fast plastic stent and minimal or no contrast infusion. Patients with previous liver transplantation.

Design outcomes

Primary

MeasureTime frame
Effectiveness of the two techniques under investigation. Effectiveness: capacity of the technique to successfully treat the condition (complex biliary stones), with complete removal of all the stones from the bile ducts, in a way that patient will not have this condition at the end of procedure. This will be verified at the end of the procedure performing a control cholangiography post stone removal.—

Secondary

MeasureTime frame
Analysis of the particularities of the stones (size in millimeters, shape oval, round or faceted and location in bile ducts segments) and their relation with the success of bile duct clearance.;Safety of the two techniques under investigation. Safety: analyzed with the occurrence of adverse events, the frequency, type, if related or not to the procedure and severity. Adverse events were verified during procedure, in 24 hours and one week.—

Countries

Brazil

Contacts

Public ContactTomazo Franzini

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

tomazof@uol.com.br+55(11)2661000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)