| CTRI Number |
CTRI/2019/06/019751 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study of ESWL versus Spyglass for pancreatic ductal stones |
|
Scientific Title of Study
|
Randomized study of extracorporeal shock wave lithotripsy versus pancreatoscopy-guided laser lithotripsy (SpyGlass DS) for pancreatic ductal stones |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy Research Foundation, Om Chambers, 123 August Kranti Marg, Mumbai, Maharashtra 400036 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research Foundation |
| Address |
Om Chambers, 123 August Kranti Marg, Mumbai 400036 |
| Type of Sponsor |
Other [Research Foundation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit Dalal |
Global Hospitals,Parel, Mumbai |
Dr Ankit Dalal, Room No 301,
Department of Digestive Sciences, Third Floor
Mumbai
MAHARASHTRA |
9840351625
ankit.dalal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K868||Other specified diseases of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 frequency of 60 shocks per minute The procedure is carried out on successive days till the desired fragmentation is achieved. This is done using fluoroscopic guidance followed by ERCP. |
| Comparator Agent |
Spyglass-DS group |
Pancreatoscopy will be performed using the next generation (SpyGlass DS; 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 conventional methods. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1. Ongoing or Recent pancreatitis <4 weeks
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Outcome of pancreatoscopy with laser lithotripsy for pancreatic ductal clearance on ERP
2. Outcome of ESWL for pancreatic ductal clearance on ERP |
At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Spyglass and ESWL |
At end of study |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pancreatic stones can be managed by surgery, endoscopy, or extracorporeal shock wave lithotripsy. Pancreatic ductal stones have a decreased incidence of successful endoscopic extraction and often require lithotripsy. Many critical patients in whom conventional surgery is a high-risk procedure can be managed by ERCP. Although ERCP with conventional methods is successful in most cases, certain stones are difficult or impossible to manage with these maneuvers. Current guidelines suggest use of extracorporeal shock wave lithotripsy (ESWL) for PD stones. In patients with chronic pancreatitis, ESWL permits stone fragmentation and removal during ERCP with some advantages over laser lithotripsy (LL) and surgery. Recently direct pancreatoscopy using the SpyGlass DS system allows direct visualization of the pancreatic ductal stones and lithotripsy can be performed using Holmium laser. Theoretically this offers several advantages; however, no randomized trials have assessed the usefulness of these modalities or superiority of one over the other. So, we aim to study the outcomes between extracorporeal shock wave lithotripsy versus pancreatoscopy-guided laser lithotripsy (SpyGlass DS) for pancreatic ductal stones in a randomised manner. |