Clinical trial NCT02703077: Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla
Official title: Endoscopic Treatment of Difficult Bile Duct Stones: Use of Direct Visualization System ("Spyglass Direct Visualization System") Associated With Electrohydraulic Lithotripsy (EHL) X Hydrostatic Balloon Dilation of the Major Duodenal Papilla
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Common Bile Duct Gallstones
Choledocholithiasis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compare 2 techniques to treat difficult bile duct stones endoscopically

Detailed description: Before enrollment of the patients into the study, the two investigators, EGHM and TAPF, will perform 10 complete cases each of ERCP (Endoscopic retrograde cholangiopancreatography) + SPYGLASS + EHL, to get more experience with the methods.

This will be a comparative study of methods, prospective, randomized study assessing the successful removal of bile duct stones considered to be difficult between the two proposed methods. A total of 100 patients will be recruited, according to the criteria for inclusion / exclusion of Appendix I. Randomization will be performed using a computer generated system. Fifty patients will be distributed in group 1 (Spyglass + electrohydraulic lithotripsy) and fifty in group 2 (with hydrostatic balloon dilation of the papilla with a extractor balloon sweep). Endoscopic retrograde cholangiopancreatography (ERCP) will be performed, and after the diagnosis of difficult stone, will be followed by randomization between the two proposed methods. In group 1, the examination with the Direct Visualization System of Bile Ducts ("Spyglass Direct Visualization System") will be held soon after the diagnosis of difficult stone and partial endoscopic papillotomy. After access to the biliary duct with the system described, and the visualization of the stone, it will be introduced gently through the working channel of a spyglass the probe to perform the electrohydraulic lithotripsy. When the fragmentation is complete the system spyglass will be removed and the pieces of stone are removed by conventional endoscopic methods. In group 2, after the diagnosis of difficult calculi and performing the partial endoscopic papillotomy, the papilla (as with papillotomy) will be dilated with a hydrostatic balloon until the maximum size allowed by the diameter of common bile duct, followed by scanning with extractor balloon. In both groups, the stone clearance will be confirmed using Spyglass cholangioscopic exploration of the bile duct. In case of failure in stone removal by some of the methods studied, it will be performed biliary drainage with plastic stent.

Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Able to give consent
* Submitted to the examination of endoscopic retrograde cholangiopancreatography (ERCP), with identification of stones in the bile duct considered difficult.
* Agreed and signed the Term of Consent.

Exclusion Criteria:

* Age below 18 years
* Incapable of giving consent
* Pregnant
* Gastrointestinal bypass surgery with previous reconstructions as a 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

Primary outcomes:
measure: Success of the intervention
timeFrame: intraoperative
Secondary outcomes:
measure: Time
timeFrame: intraoperative
measure: Adverse events
timeFrame: One week
measure: X-ray time
timeFrame: intraoperative
measure: Difficulties
timeFrame: intraoperative
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School
Study officials:
affiliation: University of Sao Paulo Medical School
name: Eduardo Moura, PhD
role: STUDY_DIRECTOR
References:
citation: Moura EG, Franzini T, Moura RN, Carneiro FO, Artifon EL, Sakai P. Cholangioscopy in bile duct disease: a case series. Arq Gastroenterol. 2014 Jul-Sep;51(3):250-4. doi: 10.1590/s0004-28032014000300015.
citation: Attam R, Freeman ML. Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg. 2009;16(5):618-23. doi: 10.1007/s00534-009-0134-2. Epub 2009 Jun 24.
citation: Stefanidis G, Christodoulou C, Manolakopoulos S, Chuttani R. Endoscopic extraction of large common bile duct stones: A review article. World J Gastrointest Endosc. 2012 May 16;4(5):167-79. doi: 10.4253/wjge.v4.i5.167.
citation: Trikudanathan G, Navaneethan U, Parsi MA. Endoscopic management of difficult common bile duct stones. World J Gastroenterol. 2013 Jan 14;19(2):165-73. doi: 10.3748/wjg.v19.i2.165.
citation: Trikudanathan G, Arain MA, Attam R, Freeman ML. Advances in the endoscopic management of common bile duct stones. Nat Rev Gastroenterol Hepatol. 2014 Sep;11(9):535-44. doi: 10.1038/nrgastro.2014.76. Epub 2014 May 27.