To investigate the efficacy and safety of pancreatoscopy-guided EHL in patients with symptomatic CP due to obstructive distal main pancreatic duct stones not having undergone previous treatment.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the technical success rate of pancreatoscopy-guided EHL
(clearance of main pancreatic duct stones).
Secondary outcome
The secondary endpoints include clinical success (reduction in pain scores and
opiate usage), ERCP related complication rates within 30 days of treatment,
number of repeat ERPs for stone clearance, length of hospital stay, perceived
burden and quality of life, and costs.
Background summary
Current treatment of patients with symptomatic chronic pancreatitis (CP) and
obstructive main pancreatic duct stones consists of extracorporeal shockwave
lithotripsy (ESWL) followed by endoscopic retrograde pancreatography (ERP) to
extract the fragmented stones. Pancreatoscopy-guided electrohydraulic
lithotripsy has shown potential value CP patients, but is a novel second-line
intervention after failed ESWL, due to the necessity of nonstandard equipment
and materials. First line intervention with pancreatoscopy-guided
electrohydraulic lithotripsy (EHL) could potentially obviate the need for ESWL
in selected patients, reducing patient burden, costs and healthcare
utilization.
Study objective
To investigate the efficacy and safety of pancreatoscopy-guided EHL in patients
with symptomatic CP due to obstructive distal main pancreatic duct stones not
having undergone previous treatment.
Study design
Non-randomized single center prospective consecutive cohort study.
Intervention
Pancreatoscopy-guided EHL, performed with a digital single-operator
cholangio-pancreaticoscopy system (Spyglass* Direct Visualization System) with
EHL (Nortech AUTOLITH system).
Study burden and risks
The burden of participation is limited since patients with chronic pancreatitis
with main pancreatic duct stones are already scheduled to undergo (multiple)
ERP(s) preceded by 3 sessions of ESWL. If pancreatoscopy-guided EHL lives up to
the promise, based on excellent performance data in the treatment of refractory
biliary stones and an outstanding safety profile, it will reduce the number of
procedures required for stone fragmentation an clearance and thereby patient
burden.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent
2. Age equal to or above 18 years (adult)
3. Symptomatic chronic pancreatitis with obstructive pancreatic duct stones (> 5 mm), in the head or neck of the pancreas.
Exclusion criteria
1. Inability to give informed consent.
2. Age less than 18 years of age.
3. Chronic pancreatitis with obstructive pancreatic duct stones, located in the body or tail of the pancreas.
4. History of treatment of pancreatic duct stones with ESWL.
5. History of surgical treatment of chronic pancreatitis.
6. Pregnancy.
7. Inability to undergo endoscopic treatment due to comorbidity.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60630.078.17 |