| CTRI Number |
CTRI/2021/03/032127 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study to assess the efficacy of oral melatonin plus rectal indomethacin versus rectal indomethacin for the prevention of post-ercp pancreatitis |
|
Scientific Title of Study
|
Randomized comparative study to assess the efficacy of Oral Melatonin plus Rectal Indomethacin versus Rectal Indomethacin for the Prophylaxis of Post-Ercp Pancreatitis |
| Trial Acronym |
PEP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Nijhawan |
| Designation |
Professor, D.M. gastroenterology |
| Affiliation |
Sawai man Singh Medical college, jaipur |
| Address |
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829272233 |
| Fax |
|
| Email |
sandeepnijhawan16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishabh gupta |
| Designation |
Senior Resident , D.M. gastroenterology |
| Affiliation |
sawai man singh medical college, jaipur |
| Address |
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN
302012
India |
| Phone |
9588248715 |
| Fax |
|
| Email |
rishabh1313@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishabh gupta |
| Designation |
Senior Resident , D.M. gastroenterology |
| Affiliation |
sawai man singh medical college, jaipur |
| Address |
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Department of gastroenterology, room no. 303 , 3rd floor , sms hospital, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN
302012
India |
| Phone |
9588248715 |
| Fax |
|
| Email |
rishabh1313@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical college and attached group of hospitals, jaipur |
|
|
Primary Sponsor
|
| Name |
BSBY Scheme Govt of Rajasthan |
| Address |
Department of Gastroenterology Room No. 303, IIIrd floor SMS hospital, jaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rajasthan medicare relief society |
SMS hospital, jaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishabh gupta |
SMS Medical college, Jaipur |
Department of Gastroenterology Room no. 303 IIIrd floor SMS hospital, jaipur
Jaipur
RAJASTHAN |
9588248715
rishabh1313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics committee sms medical college, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K830||Cholangitis, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Melatonin plus Rectal Indomethacin |
3 mg oral melatonin with 100 mg rectal indomethacin ( two 50 mg suppositories ) will be given 1 hour before the ERCP procedure |
| Comparator Agent |
Rectal Indomethacin |
100 mg rectal indomethacin ( two 50 mg suppositories ) will be given 1 hour before the ERCP procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS UNDERGOING ERCP IN THE DEPARTMENT OF GASTROENTEROLOGY, SMS HOSPITAL OVER A PERIOD OF 6 MONTHS |
|
| ExclusionCriteria |
| Details |
1) History of hypersensitivity to Indomethacin
2) History of hypersensitivity to Melatonin
3) Recent Peptic ulcer disease or active/ recent
gastrointestinal bleeding within 4 weeks.
4) Renal dysfunction (creatinine > 1.5 mg/dl)
5) NSAID use during preceding week (acetylsalicylic acid
325 mg daily or less was acceptable)
6) Acute pancreatitis during the 2 weeks before ERCP
7) History of chronic pancreatitis
8) Previous sphincterotomy
9) Refusal to participate in the study.
10) Pregnancy or lactation
11) Patients undergoing ERCP on an outpatient basis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Frequency of Post-ERCP Pancreatitis, defined according to the revised Atlanta classification.
This classification defines three degrees of severity based on the presence or absence of organ failure ( plus its duration ) and of local or systemic complications. |
within 24 hours Post ERCP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Incidence of Delayed Post - ERCP pancreatitis ( 24 hours after ERCP )
2) Severity of PEP
3) ERCP-related complications namely bleeding, perforation, and infection
4)Hydration-related complications, such as pulmonary edema and congestive heart failure |
after 24 hours post ercp , upto 30 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/03/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
It will be a prospective, Randomized Controlled comparative study to assess the efficacy of Oral Melatonin plus Rectal Indomethacin versus Rectal Indomethacin for the prevention of Post Ercp Pancreatitis. All the patients fulfilling the inclusion criteria will be randomized into two groups . Primary and secondary end points will be studied.
|