Skip to content

Study of ESWL versus Spyglass for pancreatic ductal stones

Randomized study of extracorporeal shock wave lithotripsy versus pancreatoscopy-guided laser lithotripsy (SpyGlass DS) for pancreatic ductal stones

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019751
Enrollment
56
Registered
2019-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K868- Other specified diseases of pancreas

Interventions

Intervention1: ESWL Group: ESWL will be performed using a (Dornier Compact Delta II, Germany). A maximum of 7,000 to 8,000 shocks will be delivered per session with an intensity of 70 kV at a frequenc
Boston Scientific) direct visualization system which allows direct visualization of PD stones during ERCP. The visualized stones will be fragmented using Holmium laser and stone extraction done using

Sponsors

Endoscopy Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients age >18 years of either sex with a dilated PD with ductal stones in head and proximal body, based on ultrasonography, computed tomography, magnetic resonance imaging, or previous ERCP will be included. 2. Patients who agree to sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Ongoing or Recent pancreatitis 2. Pancreatic malignancy 3. Pancreatic fluid collections 4. Presence of ascites and Pseudocysts 5. Patients with decompensated chronic liver disease 6. Patients with Coagulopathy 7. Patients with Chronic Kidney Disease 8. Pregnancy 9. Past history of pancreatic surgery 10.Isolated tail calculi 11.Patients with multiple strictures

Design outcomes

Primary

MeasureTime frame
1. Outcome of pancreatoscopy with laser lithotripsy for pancreatic ductal clearance on ERP 2. Outcome of ESWL for pancreatic ductal clearance on ERPTimepoint: At end of study

Secondary

MeasureTime frame
Safety of Spyglass and ESWLTimepoint: At end of study

Countries

India

Contacts

Public ContactDr Amit Maydeo

Baldota Institute of Digestive Sciences

amitmaydeo@gmail.com02267670311

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026