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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study compare 2 techniques to treat difficult bile duct stones endoscopically
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spyglass | Procedure | Endoscopic direct view of the bile ducts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of the intervention | Defined as complete stone removal of the bile duct | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time | From ERCP diagnosis to end of procedure (in minutes) | intraoperative |
| Adverse events | All procedure related adverse events | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomazo Franzini, MD | Contact | 5511983179968 | tomazof@uol.com.br | |
| Eduardo de Moura, PhD | Contact | 5511989918060 | eduardoghdemoura@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo Moura, PhD | University of Sao Paulo Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25296087 | Background | 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. | |
| 19551331 | 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. |
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Decision during trial
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 15, 2016 | |
| Reset | Oct 7, 2016 |
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| Balloon dilation of the papilla | Procedure | Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal |
|
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| EHL (electrohydraulic lithotripsy) | Procedure | With a probe a direct view lithotripsy will be performed |
|
| ERCP (Endoscopic retrograde cholangiopancreatography) | Procedure | Endoscopic procedure to identify and treat biliary diseases |
|
| 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 |
| 22624068 | 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. |
| 23345939 | 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. |
| 24860928 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 15, 2016 | Oct 7, 2016 |
| ID | Term |
|---|---|
| D042882 | Gallstones |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
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| ID | Term |
|---|---|
| D013105 | Sphincterotomy, Transduodenal |
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
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