Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla

Choledocholithiasis Clinical Trial

— EHL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02703077
• Other study ID #: 0784/10
• Status: Recruiting
• Phase: Phase 4
• First received: February 29, 2016
• Last updated: March 8, 2016
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2016
• Source: University of Sao Paulo General Hospital
• Contact: Tomazo Franzini, MD
• Phone: 5511983179968
• Email: tomazof[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choledocholithiasis
• Common Bile Duct Gallstones
• Gallstones

Intervention

Procedure:
• Spyglass
Endoscopic direct view of the bile ducts
• Balloon dilation of the papilla
Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal
• EHL (electrohydraulic lithotripsy)
With a probe a direct view lithotripsy will be performed
• ERCP (Endoscopic retrograde cholangiopancreatography)
Endoscopic procedure to identify and treat biliary diseases

Locations

Country	Name	City	State
Brazil	Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Boston Scientific Corporation

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of the intervention	Defined as complete stone removal of the bile duct	intraoperative
Secondary	Time	From ERCP diagnosis to end of procedure (in minutes)	intraoperative
Secondary	Adverse events	All procedure related adverse events	One week
Secondary	X-ray time	From ERCP diagnosis to end of procedure in minutes	intraoperative
Secondary	Difficulties	Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL	intraoperative