| CTRI Number |
CTRI/2020/09/027536 [Registered on: 02/09/2020] Trial Registered Prospectively |
| Last Modified On: |
20/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
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Per rectal diclofenac tablet (suppository) and inraveous fluid (Ringer lactate) are already proven for decreasing adverse effect (pancreatitis) after an endoscopic procedure (ERCP). We will be combining both methods to see whether they can further decrease the adverse effect of ERCP. |
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Scientific Title of Study
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A prospective randomized clinical study to compare efficacy of intravenous ringer lactate or diclofenac suppository or combination of both in prevention of post endoscopic retrograde cholangio-pancreatography(ERCP) pancreatitis. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Rathi |
| Designation |
Professor and Head |
| Affiliation |
Department of Gastroenterology, T.N medical college and B.Y.L Nair hospital |
| Address |
Department of Gastroenterology,717,OPD building, Nair hospital
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9322406438 |
| Fax |
|
| Email |
rathipmpp@gmail.com |
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Details of Contact Person
Public Query
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| Name |
Ravi Kacharu Thanage |
| Designation |
Assistant professor |
| Affiliation |
Department of Gastroenterology, T.N medical college and B.Y.L Nair hospital |
| Address |
Department of Gastroenterology,717,OPD building, Nair hospital
MAHARASHTRA
400008
India |
| Phone |
9028785843 |
| Fax |
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| Email |
ravi.thanage@gmail.com |
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Source of Monetary or Material Support
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| Department of Gastroenterology,T.N medical college and B.Y.L nair hospital |
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Primary Sponsor
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| Name |
Department of Gastroenterology |
| Address |
717, 7th floor, OPD building
nair hospital |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravi Thanage |
Department of Gastroenterology |
717, OPD building,Topiwala national medical college and B.Y.L nair hospital
Mumbai
MAHARASHTRA |
9028785843
ravi.thanage@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for academic research projects, T.N medical college and BYL nair ch. hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Rectal diclofenac suppository
and ringer lactate infusion |
it is given post ERCP 100 mg diclofenac suppository and ringer lactate 20ml/kg bolus and 3 ml/kg for next 8 hours |
| Comparator Agent |
Rectal diclofenac suppository |
it is given post ERCP 100 mg |
| Comparator Agent |
Ringer lactate infusion |
it is given 20 ml/kg bolus and then 3 ml/kg infusion over next 8 hours |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients having high risk factors for post ERCP pancreatitis. |
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| ExclusionCriteria |
| Details |
Pregnancy,
Patient with contraindication for diclofenac and ringer lactate,
Patient with active acute pancreatitis,
Patient not giving consent |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Decrease in incidence of post ERCP pancreatitis in combination prophylaxis group,in comparison to prophylaxis by individual therapy(rectal diclofenac OR Ringers lactate) |
After 24 hours of procedure diagnosis of pancreatitis would be looked for. |
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Secondary Outcome
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| Outcome |
TimePoints |
| Decrease in hospital stay |
24 hours after ERCP |
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Target Sample Size
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Total Sample Size="171"
Sample Size from India="171"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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07/09/2020 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Nil |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Patients
undergoing endoscopic retrograde cholangiopancreatography (ERCP) has a
risk of developing pancreatitis post ERCP. Rectal diclofenac and ringer lactate
solution infusion are proven prophylaxis to prevent post ERCP pancreatitis. We
are comparing the combination of these two prophylaxis modalities to either one
of them. Our hypothesis is that combined prophylaxis would be better than
either one of them. |