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

NCT02703077 | Unknown Phase 4 DMC

• 1 other identifier: 0784/10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Common Bile Duct Gallstones; Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• Success of the intervention

  Defined as complete stone removal of the bile duct

  intraoperative

Secondary Outcomes (4)

• Time

  intraoperative

• Adverse events

  One week

• X-ray time

  intraoperative

• Difficulties

  intraoperative

Study Arms (2)

1: ERCP + Spyglass + EHL

ACTIVE COMPARATOR

This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy)

Procedure: Spyglass; Procedure: EHL (electrohydraulic lithotripsy); Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)

2: ERCP + Balloon Dilation

ACTIVE COMPARATOR

This group after the diagnosis of difficult bile duct stones, will be submitted to Balloon dilation of the papilla

Procedure: Balloon dilation of the papilla; Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)

Interventions

Spyglass PROCEDURE

Endoscopic direct view of the bile ducts

Also known as: Cholangioscopy, Direct view cholangioscopy

1: ERCP + Spyglass + EHL

Balloon dilation of the papilla PROCEDURE

Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal

Also known as: Sphincteroplasty

2: ERCP + Balloon Dilation

EHL (electrohydraulic lithotripsy) PROCEDURE

With a probe a direct view lithotripsy will be performed

1: ERCP + Spyglass + EHL

ERCP (Endoscopic retrograde cholangiopancreatography) PROCEDURE

Endoscopic procedure to identify and treat biliary diseases

1: ERCP + Spyglass + EHL; 2: ERCP + Balloon Dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (5)

• 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.

  PMID: 25296087 BACKGROUND

• 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.

  PMID: 19551331 BACKGROUND

• 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.

  PMID: 22624068 BACKGROUND

• 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.

  PMID: 23345939 BACKGROUND

• 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.

  PMID: 24860928 BACKGROUND

MeSH Terms

Conditions

Gallstones; Choledocholithiasis

Interventions

Sphincterotomy, Transduodenal; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures

Study Officials

• Eduardo Moura, PhD

  University of Sao Paulo Medical School

  STUDY DIRECTOR

Central Study Contacts

Tomazo Franzini, MD

CONTACT

5511983179968; tomazof@uol.com.br

Eduardo de Moura, PhD

CONTACT

5511989918060; eduardoghdemoura@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 9, 2016

Record last verified: 2016-02

Locations

BR (1)