| CTRI Number |
CTRI/2018/04/013396 [Registered on: 20/04/2018] Trial Registered Prospectively |
| Last Modified On: |
18/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of drug (epinephrine spray on papilla) to prevent pancreatitis resulting from Endoscopic retrograde cholangiopancreatography procedure. |
|
Scientific Title of Study
|
Role of epinephrine spray on papilla for prevention and prophylaxis of post ERCP Pancreatitis. |
| Trial Acronym |
POEP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gul javid |
| Designation |
Professor Gastroenterology |
| Affiliation |
Sher-i-kashmir Institute of Medical Sciences,srinagar kashmir. |
| Address |
Department of Gastroenterology. Sher-i-kashmir Institute of Medical Sciences, srinagar kashmir.
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9419057093 |
| Fax |
|
| Email |
guljavid@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gul javid |
| Designation |
Professor Gastroenterology |
| Affiliation |
Sher-i-kashmir Institute of Medical Sciences,srinagar kashmir. |
| Address |
Department of Gastroenterology. Sher-i-kashmir Institute of Medical Sciences, srinagar kashmir.
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9419057093 |
| Fax |
|
| Email |
guljavid@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hilal Ahmad Dar |
| Designation |
DM Student |
| Affiliation |
Sher-i-kashmir Institute of Medical Sciences,srinagar kashmir. |
| Address |
Department of Gastroenterology. Sher-i-kashmir Institute of Medical Sciences, srinagar kashmir.
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9419313331 |
| Fax |
|
| Email |
drhilaldar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sher-i-Kashmir Institute of Medical Sciences. |
|
|
Primary Sponsor
|
| Name |
Department of Gastroenterology Sherikashmir Institute of Medical Sciences |
| Address |
SKIMS,SOURA KASHMIR. PIN CODE-190011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gul javid |
Sher-i-kashmir Institute of Medical Sciences |
Department of Gastroenterology and Hepatology.
Room no- 247.
Srinagar
JAMMU & KASHMIR |
9419057093
guljavid@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SKIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
400 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited for the study. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental: Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla |
Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla |
| Comparator Agent |
Placebo Comparator: Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla |
Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years
2.Both males and females
3.Signed consent and agreed to have proper follow-up as advised.
|
|
| ExclusionCriteria |
| Details |
1. Acute / chronic pancreatitis.
2. Pregnancy
3. Allergy / contraindications to epinephrine.
4. Psychological or medical conditions that would not permit the patient to complete the study or sign the consent form.
5. Billroth II or Roux-en-Y anatomy.
6. chronic renal disease ( creatinine > 1.5 mg/dl )
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis [ Time Frame: PEP occurence rate at 24 h after ERCP in two groups.
If the serum amylase is 3 times higher than the normal values after 24 hours of ERCP in patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). |
at 3 hours after ERCP, serum amylase will be done and at 24 hours after ERCP, serum amylase will be done again along with ultrasonography of abdomen. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event. |
at 3 hours and at 24 hours after ERCP, serum amylase will be done. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "997"
Final Enrollment numbers achieved (India)="997" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
25/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is well recognized complication with significant morbidity and mortality. The possible mechanism is papillary edema caused by manipulations during ERCP. The papillary edema may cause temporary outflow obstuction of pancreatic juice and may lead to increase in ductal pressure resulting in post ERCP pancreatitis. Topical application of epinephrine spray may reduce papaillary edema and may be effective in preventing post ERCP pancreatitis. Hence we are conducting this prospective randomized controlled study to determine the effect of epinephrine spray on papilla for prevention of post ERCP pancreatitis.400 consecutive patients older than 18 years, who are admitted for diagnostic or therapeutic ERCP at Sher-i-kashmir Institute of Medical sciences in department of Gastroenterology will be recruited for this study. Patients will be randomized using opaque sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine ( drug group) or saline (control group) on papilla.we will randomly distribute patients in two groups. Control group of patients will receive 100 mg of diclofenac rectal suppository half an hour before start of ERCP procedure followed by 20 ml of normal saline spray on the duodenal papilla over a period of one minute using ERCP cannulation catheter at the end of procedure. Experimental ( epinephrine group) of patients will receive 100 mg of diclofenac rectal suppository half an hour before start of ERCP procedure followed by 20 ml of 0.02% epinephrine spray on the duodenal papilla over a period of one minute using ERCP cannultion catheter at the end of procedure. Post ERCP pancreatitis will be defined by consensus guidelines as 1. New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2. serum amylase or lipase > 3 times the upper limit of normal 24 hours after ERCP procedure and 3. hospitalization or prolongation of existing hospitalization for at least 2 days. Severity of post ERCP pancreatitis will also be defined using the consensus grading as Mild post ERCP pancreatitis that results in hospitalization for < 3 days. Moderate post ERCP pancreatitis will be defined as pancreatitis that results in hospitalization for 4-10 days. Severe post ERCP pancreatitis will be defined as pancreatitis that results in hospitalization for > 10 days, or leads to the developement of pancreatic necrosis or requires additional endoscopic, percutaneous or surgical interventions. Severity of post ERCP pancreatitis will also be defined using modified Atlanta criteria. |