Clinical trial NCT04131010: Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
Official title: Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis, Calcific
Pancreatitis, Chronic
Lead sponsor: Evangelisches Krankenhaus Düsseldorf
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: International prospective multicenter cohort study
Primary purpose: TREATMENT

Brief summary: Investigation of the efficacy and safety of digital catheter-based pancreatoscopy (DCP) for the Treatment of symptomatic Stones of the pancreatic duct in selected patients with chronic calcifying pancreatitis (CCP)

Detailed description: Background Endoscopic treatment of patients with chronic calcifying pancreatitis (CCP) is still challenging and controversially discussed. The goal is symptom control and relief of pain, which can be achieved by draining an obstructed main pancreatic duct (MPD) and/or removal of ductal stones. The 2012 European Society of Gastrointestinal Endoscopy (ESGE)- Guidelines recommends ESWL as a first step for patients with uncomplicated painful chronic pancreatitis and radiopaque stones ≥5mm obstructing the MPD. However, limitations of ESWL (extracorporeal shockwave lithotripsy ) include its limited availability, a likely need for multiple sessions and often repeated ERCP (endoscopic retrograde cholangiopancreatography) sessions for removal of stone fragments or treatment of associated strictures.

Pancreatoscopically guided management of pancreatic stones offers a potential alternative to ESWL. However, the numbers of studies and enrolled patients are still low. In 2015 single operator video cholangioscopy (SpyGlassDS, Boston Scientific) was introduced. Available data on its use for pancreatoscopy is limited. The technique provides digital imaging with a higher resolution and improved maneuverability compared to the legacy fiberoptic system. In addition, the working channel was enlarged to a diameter of 1.3 mm. Although SOVP have shown promise in CCP, studies to date generally have been limited by: retrospective design, relatively small and mixed patient populations, short follow-up periods, different clinical and technical endpoints, and, often, a single-center design. Therefore, the investigators designed a prospective multicenter cohort study to evaluate long-term clinical efficacy, technical success and safety of SOVP.

Eligibility criteria: Inclusion Criteria:

* Eligible patients are adults (≥ 18 years of age) with a signed informed consent with:
* symptomatic chronic pancreatitis (recurrent pain attacks, history of pain for at least 3 months), and
* ≤3 radiopaque stones ≥5mm obstructing the MPD in the pancreatic head and/or corpus.

Exclusion Criteria:

* - Health status ASA 4
* Pregnancy
* Coagulopathy (INR≥2.0, Platelets \< 70/nl)
* Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
* Any medical contraindication to ERCP, deep sedation or general anesthesia
* History of chronic symptomatic pancreatitis of more than 3-4 years\[9\]
* History of daily use of opioids except Tramadol for more than 6 months in the last 2 years
* Episode of biliary obstruction in the previous 2 months (defined as jaundice or bilirubin levels \>=2,5mg/dl or CBD stent
* Auto-Immune Pancreatitis or IgG4 associated pancreatitis
* Altered GI anatomy, previous failures of endoscopic approach to the papilla
* Abdominal pain not attributable to CP
* Any suspicion of pancreatic cancer
* Current symptomatic WON
* More than one ductal stricture in the pancreatic head or body
* Previous ESWL pancreatic stones
* Age \<18

Primary outcomes:
measure: Number of participants with complete clearance of the MPD from ≤3 stones in the pancreatic head and/or body by means of SOVP in ≤3 treatment sessions
timeFrame: at baseline visit
Secondary outcomes:
measure: Number of treatment sessions
timeFrame: within three months
measure: Procedural time
timeFrame: at baseline visit
measure: Number of participants with Adverse events (post procedure and at 30 days)
timeFrame: at baseline visit and 30 days after the invention
measure: Rate of pancreatoscopic visualization of the targeted stones(s) and initiation of lithotripsy by using the Single-Operator Video pancreatoscopy (SOVP)
timeFrame: at baseline visit
measure: Number of patients with stone fragmentation (particles ≤3mm, or decreased stone density at X-ray, an increased stone surface and heterogenity of the stone(s) which may fill the MPD and adjacent side branches
timeFrame: at baseline visit
measure: Number of patients with ductal drainage after complete or incomplete ductal clearance (e.g. by placement of an endoprosthesis)
timeFrame: at baseline visit
measure: Determination by MRCP of the diameter of the MPD prior to treatment and at 6 months after the final intervention
timeFrame: prior procedure and 6 months after procedure
measure: Rate of patients with improved Clinical Outcome or complications as assessed by Numeric Rating scale (NRS) for pain, Izbicki Pain Score and number of pain attacks determined at 30 days, 6 and 12 months after the final intervention by means of SOVP
timeFrame: 30 days, 6 months and 12 months after procedure
measure: Change of Quality of life as assessed by the Short Form -12 questionnaire prior to treatment and 6 months after the final intervention
timeFrame: prior treatrment, 6 months after treatment and at the last procedure visit (procedure I, II or III as applicable)
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
state: NRW
Study officials:
References: