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

Study Overview
=================
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.

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

Conditions
-----------------
Common Bile Duct Gallstones, Choledocholithiasis

Intervention / Treatment
-----------------
* Procedure: Spyglass
* Procedure: Balloon dilation of the papilla
* Procedure: EHL (electrohydraulic lithotripsy)
* Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: ERCP + Spyglass + EHL<br>This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy) | Procedure: Spyglass<br>* Endoscopic direct view of the bile ducts<br>* Other names: Direct view cholangioscopy;Procedure: EHL (electrohydraulic lithotripsy)<br>* With a probe a direct view lithotripsy will be performed<br>Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)<br>* Endoscopic procedure to identify and treat biliary diseases<br>|
| Active Comparator: 2: ERCP + Balloon Dilation<br>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<br>* Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal<br>* Other names: Sphincteroplasty;Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)<br>* Endoscopic procedure to identify and treat biliary diseases<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the intervention | Defined as complete stone removal of the bile duct | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | From ERCP diagnosis to end of procedure (in minutes) | intraoperative | 
| Adverse events | All procedure related adverse events | One week | 
| X-ray time | From ERCP diagnosis to end of procedure in minutes | intraoperative | 
| Difficulties | Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL | intraoperative |