| CTRI Number |
CTRI/2016/10/007335 [Registered on: 05/10/2016] Trial Registered Prospectively |
| Last Modified On: |
05/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A STUDY TO EVALUATE THE ROLE OF PROPHYLACTIC OCTREOTIDE IN PREVENTING ERCP INDUCED PANCREATITIS |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMISED CONTROL TRIAL TO EVALUATE THE ROLE OF PROPHYLACTIC OCTREOTIDE IN PREVENTING ERCP INDUCED PANCREATITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMIR DEOLEKAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY 2ND FLOOR OPD BUILDING SETH GS MEDICAL COLLEGE AND KEM HOSPITAL PAREL MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820222313 |
| Fax |
|
| Email |
samirdeolekar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUJ SHARMA |
| Designation |
PG resident |
| Affiliation |
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY 2ND FLOOR OPD BUILDING SETH GS MEDICAL COLLEGE AND KEM HOSPITAL PAREL MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7303907379 |
| Fax |
|
| Email |
anuj9863@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUJ SHARMA |
| Designation |
PG resident |
| Affiliation |
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY 2ND FLOOR OPD BUILDING SETH GS MEDICAL COLLEGE AND KEM HOSPITAL PAREL MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7303907379 |
| Fax |
|
| Email |
anuj9863@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
DEPARTMENT OF GENERAL SURGERY SECOND FLOOR OPD BUILDING ACHARYA DHONDE MARG PAREL MUMBAI 400012 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| SAMIR DEOLEKAR |
SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
DEPARTMENT OF GENERAL SURGERY SECOND FLOOR OPD BUILDING SETH GS MEDICAL COLLEGE AND KEM HOSPITAL ACHARYA DHONDE MARG PAREL MUMBAI 400012
Mumbai
MAHARASHTRA |
7303907379
anuj9863@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-I SETH GS MEDICAL COLLEGE AND KEM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS UNDERGOING ERCP PROCEDURE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% NORMAL SALINE |
3 doses of 100 micrograms will be given 12 hours, 6 hours and 45 minutes before the procedure. after the procedure, 100 microgram dose will be given after 6 hours and 12 hours.
Route of administration: subcutaneous doses
Patient will be assesed for 48 hours with any of the two: 1. abdominal pain. Yes/No
2. Serum Amylase or Lipase levels above three times the normal level at 12 hours.
3. CT/ USG imaging suggestive of pancreatitis. |
| Intervention |
OCTREOTIDE |
3 doses of 100 micrograms will be given 12 hours, 6 hours and 45 minutes before the procedure. after the procedure, 100 microgram dose will be given after 6 hours and 12 hours.
Route of administration: subcutaneous doses
Patient will be assesed for 48 hours with any of the two: 1. abdominal pain. Yes/No
2. Serum Amylase or Lipase levels above three times the normal level at 12 hours.
3. CT/ USG imaging suggestive of pancreatitis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. WILLING TO PARTICIPATE IN THE STUDY
2. UNDERGOING ERCP FOR A VALID INDICATION
3. FOLOOWING UP WITH POST ERCP EVALUATION FOR DIAGNOSING PANCREATITIS |
|
| ExclusionCriteria |
| Details |
1. PREGNANCY AND LACTATION
2. CHRONIC RENAL FAILURE
3. ACUTE MYOCARDIAL INFARCTION DURING THE LAST 3 MONTHS BEFORE PROCEDURE
4. HIV POSITIVE OR ANY OTHER IMMUNO-COMPROMISED STATE
5. PLANNED BILIARY STENT REMOVAL OR EXCHANGE
6. HISTORY OF ALCOHOL OR OTHER DRUG ABUSE
7.RECENT USE OF NARCOTIC ANALGESIC OR ANTICHOLINERGIC MEDICATION
8. HISTORY OF CHRONIC PANCREATITIS OR OTHER DISEASE KNOWN TO EFFECT PANCREATIC SECRETION (VAGOTOMY, GASTRECTOMY, INFLAMMATION)
9. REFUSAL TO PARTICIPATE
10. PATIENTS WITH PREVIOUS HISTORY OF ERCP INDUCED PANCREATITIS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % WITH ERCP INDUCED PANCREATITIS ACCORDING TO THE MODIFIED ATLANTA CLASSIFICATION |
48 HOURS THOUGH . The length of hospital stay will be decided by the treating unit under which the patient is admitted. In case, the patient is discharged before 48 hours, he or she will be followed on a telephonic interview basis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/10/2016 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endoscopic retrograde cholangio pancreaticography (ERCP) is a
very useful diagnostic and therapeutic modality for Hepatobiliary and
Pancreatic Pathologies. it is a minimal invasive techniques for diagnosing and
treating various hepatobiliary diseases which demanded major surgical
explorations in the past. The various complications of this procedure include
pancreatitis, hemorrhage, perforation and other
pulmonary cardiovascular abnormalities. Pancreatitis is the most common
and the most fearful of all these complications. The various measures include
both pharmacologic and procedural measures to reduce the incidence of the same.
Amongst the
pharmacologic measures various agents have been tried and studied to know whether
they have a role for preventing pancreatitis. Octreotide, a somatostatin
analogue reduces enzyme release and inhibits activation of pancreatic enzymes.
Our study would evaluate the incidence of ERCP induced pancreatitis and would
further establish if prophylactic use of octreotide would reduce the incidence
of post ERCP induced pancreatitis , significantly or not.
|