| CTRI Number |
CTRI/2019/06/019750 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of pancreatic ductal stone density on computed tomography for predicting outcome of ESWL |
|
Scientific Title of Study
|
Assessment of pancreatic ductal stone density on computed tomography for predicting outcome of extracorporeal shock wave lithotripsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankit Dalal |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 301, Department of Digestive Sciences, Third floor
Global Hospitals Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9840351625 |
| Fax |
|
| Email |
ankit.dalal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Dalal |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 302, Department of Digestive Sciences, Third floor
Global Hospitals Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9840351625 |
| Fax |
|
| Email |
ankit.dalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Dalal |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 302, Department of Digestive Sciences, Third floor
Global Hospitals Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9840351625 |
| Fax |
|
| Email |
ankit.dalal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy research foundation,Om Chambers 123 August Kranti Marg, Mumbai - 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 Gaurav Patil |
Baldota Institute of Digestive Sciences |
Room No 302, Third Floor, Baldota Institute of Digestive Sciences, Global Hospitals, Parel, Mumbai
Mumbai
MAHARASHTRA |
9650355454
gauravkpatil@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Chronic calcific Pancreatitis either sex aged 18 years and above
2. PD radiopaque Calculi Size >5mm
3. Patients who agree to sign informed consent |
|
| ExclusionCriteria |
| Details |
1. Ongoing or Recent pancreatitis <4 weeks
2. Pancreatic malignancy
3. Pancreatic fluid collections
4. Presence of ascites
5. Patients with cirrhosis of Liver
6. Patients with Coagulopathy
7. Patients with Chronic Kidney Disease
8. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcome of ESWL and subsequent pancreatic ductal clearance on ERP based on the stone density on computed tomography. |
At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of ESWL |
At end of study |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Extraction of large pancreatic calculi is challenging for the endoscopist. Extracorporeal shockwave lithotripsy (ESWL) is an excellent tool for patients with large pancreatic calculi that are not amenable to routine endotherapy. Pancreatic calculi in the head and body are targeted by ESWL, with an aim to fragment them to < 3 mm diameter so that they can be extracted by subsequent endoscopic retrograde cholangiopancreatography (ERCP). Drainage of the main pancreatic duct (MPD) with ERCP alone is often unsuccessful; so, ESWL is used to fragment large pancreatic stones before ERCP. After pulverization of the stones by ESWL, the fragmented stones can be retrieved endoscopically. Long-term follow up studies have shown that ESWL combined with endoscopic drainage of the pancreatic duct relieves pain and may avoid the need for surgery in approximately two-thirds of patients. Some studies have suggested that breaking of stones to <2 mm in size by ESWL alone is effective in providing relief in pancreatic pain as these small stones are spontaneously cleared. Patients who cannot be managed endoscopically need to be treated surgically. However pancreatic surgery is associated with substantial morbidity (20-40%) and mortality (2-5%). ESWL has advantages over surgery viz. it is minimally invasive; there is usually no need for general anaesthesia and has low complications. Till date there has been just one study across the world which has looked for density of pancreatic ductal stones on imaging to predict outcomes for ESWL. Therefore this study is aimed to evaluate the outcome of ESWL based on computerized tomography characteristics for pancreatic ductal stones. |