Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis

NCT04131010 | Unknown FDA Device

• 1 other identifier: SPYGlass DS
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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)

Conditions

Pancreatitis, Calcific; Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

  Number of patients where complete clearance of the MPD could be reached within three Treatment sessions of SOVP

  at baseline visit

Secondary Outcomes (9)

• Number of treatment sessions

  within three months

• Procedural time

  at baseline visit

• Number of participants with Adverse events (post procedure and at 30 days)

  at baseline visit and 30 days after the invention

• Rate of pancreatoscopic visualization of the targeted stones(s) and initiation of lithotripsy by using the Single-Operator Video pancreatoscopy (SOVP)

  at baseline visit

• 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

  at baseline visit

Study Arms (1)

SpyGlass Pancreatoscopy

EXPERIMENTAL

ERP with direct pancreatoscopy

Device: single operator video cholangioscopy

Interventions

single operator video cholangioscopy DEVICE

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. Retrospective data showed an overall technical success rate for single-operator video pancreatoscopy (SOVP) guided treatment of pancreatic stones of 95%

SpyGlass Pancreatoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Evangelisches Krankenhaus Düsseldorf: lead

Study Sites (1)

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40217, Germany

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Calcific; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Gerges, Dr.

CONTACT

+49 211 919 1605; Christian.Gerges@evk-duesseldorf.de

Torsten Beyna, Dr.

CONTACT

+49 211 919 1605; Torsten.Beyna@evk-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: International prospective multicenter cohort study

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: October 18, 2019
• Study Start: May 31, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)