Pancreatitis, CalcificNCT04131010
Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
A study testing single operator video cholangioscopy in people with Pancreatitis, Calcific and Pancreatitis, Chronic, run by Evangelisches Krankenhaus Düsseldorf at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Calcific, Pancreatitis, Chronic
- What is being tested?
- single operator video cholangioscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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]
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40217
Christian Gerges, Dr., +49 211 919 1605, Christian.Gerges@evk-duesseldorf.de
About this study
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)
Read the 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.
- Conditions
- Pancreatitis, Calcific, Pancreatitis, Chronic
- Being tested
- single operator video cholangioscopy
- Medical subject headings
- Pancreatitis, Calcific, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single operator video cholangioscopyDevice
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%
| Study group | Role | What they receive |
|---|---|---|
| SpyGlass Pancreatoscopy | Experimental | ERP with direct pancreatoscopy Receives: Device: single operator video cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline visit
Secondary outcomes (9)
Number of treatment sessions
Number of Treatment sessions which are necessary to reach complete clearanceof the MPD
Measured: within three months
Procedural time
Time for the procedure from beginning to the end of the intervention
Measured: at baseline visit
Number of participants with Adverse events (post procedure and at 30 days)
Incidence of Treatment-emergent Adverse Events as reported by the patients or as detected during the visits or by unplanned hospitalization
Measured: 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)
Determined by number of patients where the targeted Stones can be made visuable during the intervention
Measured: 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
Number of patients where the Stones can be fragmented during the intervention
Measured: at baseline visit
Number of patients with ductal drainage after complete or incomplete ductal clearance (e.g. by placement of an endoprosthesis)
Measured: at baseline visit
Determination by MRCP of the diameter of the MPD prior to treatment and at 6 months after the final intervention
Measured: prior procedure and 6 months after procedure
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
Self-reported pain Status as assessed by the pain assessments NRS for pain and Izbicki pain Score as well as self-reported pain attacks
Measured: 30 days, 6 months and 12 months after procedure
Change of Quality of life as assessed by the Short Form -12 questionnaire prior to treatment and 6 months after the final intervention
Self-reported Quality of life as assessed by the Short Form -12 questionnaire (this questionnaire is evaluated centrally by the rights-holding company), answering 12 questions regarding Quality of Life
Measured: prior treatrment, 6 months after treatment and at the last procedure visit (procedure I, II or III as applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start31 May 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, CalcificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- International prospective multicenter cohort study
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Düsseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131010
- Sponsor's protocol ID
- SPYGlass DS
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT04131010
- Acronym / sponsor ID
- SPYGlass DS
- Conditions
- Pancreatitis, Calcific, Pancreatitis, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Evangelisches Krankenhaus DüsseldorfUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- International prospective multicenter cohort study
| Arm | Type | Receives |
|---|---|---|
| SpyGlass Pancreatoscopy | Experimental | Device: single operator video cholangioscopyERP with direct pancreatoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single operator video cholangioscopyThe 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% | Device | SpyGlass Pancreatoscopy |
Primary outcome
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
Time frame: at baseline visit
Number of patients where complete clearance of the MPD could be reached within three Treatment sessions of SOVP
9 secondary outcomes
Number of treatment sessions
Time frame: within three months
Procedural time
Time frame: at baseline visit
Number of participants with Adverse events (post procedure and at 30 days)
Time frame: 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)
Time frame: 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
Time frame: at baseline visit
Number of patients with ductal drainage after complete or incomplete ductal clearance (e.g. by placement of an endoprosthesis)
Time frame: at baseline visit
Determination by MRCP of the diameter of the MPD prior to treatment and at 6 months after the final intervention
Time frame: prior procedure and 6 months after procedure
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
Time frame: 30 days, 6 months and 12 months after procedure
Change of Quality of life as assessed by the Short Form -12 questionnaire prior to treatment and 6 months after the final intervention
Time frame: prior treatrment, 6 months after treatment and at the last procedure visit (procedure I, II or III as applicable)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single operator video cholangioscopy in people with Pancreatitis, Calcific and Pancreatitis, Chronic, run by Evangelisches Krankenhaus Düsseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Gerges, Dr. (+49 211 919 1605, Christian.Gerges@evk-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: at baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.