A STUDY TO EVALUATE THE ROLE OF PROPHYLACTIC OCTREOTIDE IN PREVENTING ERCP INDUCED PANCREATITIS

Phase 3

Not yet recruiting

• Conditions: PATIENTS UNDERGOING ERCP PROCEDURE

• Registration Number: CTRI/2016/10/007335
• Lead Sponsor: SETH GS MEDICAL COLLEGE AND KEM HOSPITAL

Brief Summary

Endoscopic retrograde cholangio pancreaticography (ERCP) is avery useful diagnostic and therapeutic modality for Hepatobiliary andPancreatic Pathologies. it is a minimal invasive techniques for diagnosing andtreating various hepatobiliary diseases which demanded major surgicalexplorations in the past. The various complications of this procedure includepancreatitis, hemorrhage, perforation and other pulmonary cardiovascular abnormalities. Pancreatitis is the most commonand the most fearful of all these complications. The various measures includeboth pharmacologic and procedural measures to reduce the incidence of the same.

Amongst thepharmacologic measures various agents have been tried and studied to know whetherthey have a role for preventing pancreatitis. Octreotide, a somatostatinanalogue reduces enzyme release and inhibits activation of pancreatic enzymes.Our study would evaluate the incidence of ERCP induced pancreatitis and wouldfurther establish if prophylactic use of octreotide would reduce the incidenceof post ERCP induced pancreatitis , significantly or not.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2016-05-10
• Study Start: 2016-08-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• WILLING TO PARTICIPATE IN THE STUDY 2.
• UNDERGOING ERCP FOR A VALID INDICATION 3.
• FOLOOWING UP WITH POST ERCP EVALUATION FOR DIAGNOSING PANCREATITIS.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% 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.

Trial Locations

Locations (1)

SETH GS MEDICAL COLLEGE AND KEM HOSPITAL; 🇮🇳 Mumbai, MAHARASHTRA, India

SETH GS MEDICAL COLLEGE AND KEM HOSPITAL

🇮🇳Mumbai, MAHARASHTRA, India

SAMIR DEOLEKAR

Principal investigator

7303907379

anuj9863@gmail.com