Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis (ML_vs_EHL)
Primary Purpose
Gallstone, Lithiasis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ML lithotripsy
EHL lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Gallstone focused on measuring Gallstone, Lithiasis, ML lithotripsy, EHL lithotripsy
Eligibility Criteria
Inclusion Criteria:
- All patients with "difficult" biliary tract lithiasis that could not be treated by standard techniques, such as balloon and/or basket catheter under fluoroscopic vision.
Exclusion Criteria:
- surgically-altered gastrointestinal anatomy
- any evidence of biliopancreatic malignancy
- patients under 18 years of age
- patients in a state of pregnancy or are breastfeeding
- no informed consent
Sites / Locations
- Azienda USL di BolognaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
mechanical intracanal (ML) lithotripsy
electrohydraulic intracolangioscopic (EHL) lithotripsy
Arm Description
TTS mechanical lithotripter
electrohydraulic lithotripsy with Autolith probe
Outcomes
Primary Outcome Measures
ML - EHL comparison
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
Secondary Outcome Measures
effective clearance of the biliary tract
Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures.
Comparison of the safety of the treatments under study
Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04970030
Brief Title
Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis
Acronym
ML_vs_EHL
Official Title
Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Usl di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy.
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
Detailed Description
Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy.
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session.
The secondary objectives of the study are as follows:
Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures.
Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding).
Patients that can be enrolled:
All patients with "difficult" biliary tract lithiasis that could not be treated by standard techniques, such as balloon and/or basket catheter under fluoroscopic vision.
Patients cannot be enrolled:
if they have a surgically-altered gastrointestinal anatomy
if they have any evidence of biliopancreatic malignancy
if they are under 18 years of age
if they are in a state of pregnancy or are breastfeeding
if it's impossible to obtain informed consent
If, while performing ERCP for choledocholithiasis, stones are found that cannot be removed using standard treatment, they will be treated by assigning these patients to either the treatment group with ML under fluoroscopic vision or to the EHL treatment group.
Patients will be assigned using a randomization method in blocks with a ratio of 1:1 for each patient enrolled.
Subjects will undergo ERCP, either under general anesthesia, or under observation by an anesthesiologist, and depending on which group they have been assigned to, will be treated with:
EHL: after administration of IV antibiotic therapy, we will proceed to cholangioscopy with SpyGlass ™ DS (Boston Scientific Corporation, USA), treatment of difficult biliary lithiasis with electrohydraulic lithotripsy with Autolith probe (Northgate Technologies Inc USA) and subsequent complete cleaning of the biliary tract using the fluoroscopic technique.
ML: we will proceed under fluoroscopic vision with TTS mechanical lithotripter (Trapezoid, RX Wireguided Retrieval Basket, Boston Scientific) with mechanical fragmentation of the stone and subsequent complete cleaning of the biliary tract using the fluoroscopic technique.
During each procedure, the following will be recorded:
the execution time from the insertion of the cholangioscope or lithotripter inside the biliary tract until the complete cleaning of the biliary tract is finished.
the occurrence of possible adverse events related to the procedures and/or anesthetic issues.
any failure of a technique and / or the need to switch a patient to the other treatment group.
At least 50 patients eligible for the study will be required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone, Lithiasis
Keywords
Gallstone, Lithiasis, ML lithotripsy, EHL lithotripsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mechanical intracanal (ML) lithotripsy
Arm Type
Active Comparator
Arm Description
TTS mechanical lithotripter
Arm Title
electrohydraulic intracolangioscopic (EHL) lithotripsy
Arm Type
Experimental
Arm Description
electrohydraulic lithotripsy with Autolith probe
Intervention Type
Procedure
Intervention Name(s)
ML lithotripsy
Intervention Description
we will proceed under fluoroscopic vision with TTS mechanical lithotripter (Trapezoid, RX Wireguided Retrieval Basket, Boston Scientific) with mechanical fragmentation of the stone and subsequent complete cleaning of the biliary tract using the fluoroscopic technique.
Intervention Type
Procedure
Intervention Name(s)
EHL lithotripsy
Intervention Description
after administration of IV antibiotic therapy, we will proceed to cholangioscopy with SpyGlass ™ DS (Boston Scientific Corporation, USA), treatment of difficult biliary lithiasis with electrohydraulic lithotripsy with Autolith probe (Northgate Technologies Inc USA) and subsequent complete cleaning of the biliary tract using the fluoroscopic technique
Primary Outcome Measure Information:
Title
ML - EHL comparison
Description
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
Time Frame
1 day
Secondary Outcome Measure Information:
Title
effective clearance of the biliary tract
Description
Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures.
Time Frame
30 days
Title
Comparison of the safety of the treatments under study
Description
Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All patients with "difficult" biliary tract lithiasis that could not be treated by standard techniques, such as balloon and/or basket catheter under fluoroscopic vision.
Exclusion Criteria:
surgically-altered gastrointestinal anatomy
any evidence of biliopancreatic malignancy
patients under 18 years of age
patients in a state of pregnancy or are breastfeeding
no informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Cennamo, Md
Phone
+39 051 6478844
Email
vincenzo.cennamo@ausl.bo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Cennamo
Phone
+39 051 6478844
Email
vincenzo.cennamo@ausl.bo.it
Facility Information:
Facility Name
Azienda USL di Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Cennamo, MD
Phone
+39 051 6478844
Email
vincenzo.cennamo@ausl.bo.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis
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