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Common Bile Duct GallstonesPhase 4EHLNCT02703077

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

A Phase 4 study testing Spyglass, Balloon dilation of the papilla and EHL (electrohydraulic lithotripsy) in people with Common Bile Duct Gallstones and Choledocholithiasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study compare 2 techniques to treat difficult bile duct stones endoscopically Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Spyglass, Balloon dilation of the papilla and EHL (electrohydraulic lithotripsy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBrazil
Study dates
Feb 2016to Feb 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Tomazo Franzini, MD contact

5511983179968

tomazof@uol.com.br

Eduardo de Moura, PhD contact

5511989918060

eduardoghdemoura@gmail.com

Brazil1 site, 1 recruiting

  • Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School

    São Paulo, São Paulo, 05403000

    Tomazo Franzini, MD, 551126617579, tomazof@uol.com.br

    Eduardo de Moura, PhD, 551126616460, eduardoghdemoura@gmail.com

    Recruiting

Other trials in Brazil

About this study

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

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

Read the 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.

Being tested
Spyglass, Balloon dilation of the papilla, EHL (electrohydraulic lithotripsy), ERCP (Endoscopic retrograde cholangiopancreatography)
Medical subject headings
Gallstones, Choledocholithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpyglassProcedure or surgery

    Also called Cholangioscopy, Direct view cholangioscopy

    Endoscopic direct view of the bile ducts

  • Balloon dilation of the papillaProcedure or surgery

    Also called Sphincteroplasty

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

  • EHL (electrohydraulic lithotripsy)Procedure or surgery

    With a probe a direct view lithotripsy will be performed

  • ERCP (Endoscopic retrograde cholangiopancreatography)Procedure or surgery

    Endoscopic procedure to identify and treat biliary diseases

Study groups in NCT02703077
Study groupRoleWhat they receive
1: ERCP + Spyglass + EHLActive comparatorThis group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy)
Receives: Procedure: Spyglass; Procedure: EHL (electrohydraulic lithotripsy); Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)
2: ERCP + Balloon DilationActive comparatorThis group after the diagnosis of difficult bile duct stones, will be submitted to Balloon dilation of the papilla
Receives: Procedure: Balloon dilation of the papilla; Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of the intervention

    Defined as complete stone removal of the bile duct

    Measured: intraoperative

Secondary outcomes (4)

  1. Time

    From ERCP diagnosis to end of procedure (in minutes)

    Measured: intraoperative

  2. Adverse events

    All procedure related adverse events

    Measured: One week

  3. X-ray time

    From ERCP diagnosis to end of procedure in minutes

    Measured: intraoperative

  4. Difficulties

    Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02703077
Sponsor's protocol ID
0784/10
Acronym
EHL
Status last verified
Feb 2016
First submitted
29 Feb 2016
Last updated
9 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Decision during trial

Publications

  • 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.

    PubMed 25296087

  • 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.

    PubMed 19551331

  • 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.

    PubMed 22624068

  • 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.

    PubMed 23345939

  • 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.

    PubMed 24860928

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Spyglass, Balloon dilation of the papilla and EHL (electrohydraulic lithotripsy) in people with Common Bile Duct Gallstones and Choledocholithiasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tomazo Franzini, MD (5511983179968, tomazof@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of the intervention (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02703077, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.

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