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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05945797
Other study ID # 001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date November 2023

Study information

Verified date November 2023
Source Gujranwala medical college District Headquarters Hospital, Gujranwala
Contact Muhammad Nabeel Shafqat
Phone +923000426232
Email nabeelshafqat89@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this clinical trial is to evaluate the effects of dexamethasone on common bile duct cannulation time during endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary pathologies. The study will also study the effects of dexamethasone on total procedure time and total fluoroscopy time during ERCP. Participants will be divided into two groups, treatment group and placebo group. Patients in treatment group will receive dexamethasone and those in placebo group will be given normal saline before undergoing ERCP. The results in both groups will be compared to determine the effects of dexamethasone.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: 18 years or above - Both genders, male and female patients Exclusion Criteria: - Age younger than 18 years or below - Pregnant females - Pre existing stent in CBD or pancreatic duct - Previous history of ERCP - Patients with billroth II surgery - Anatomical abnormalities - Lack of competence in patients - Roux en Y gastric bypass - Patients with contra indications for steroids like DM

Study Design


Intervention

Drug:
Dexamethasone 4mg
An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.

Locations

Country Name City State
Pakistan Gujranwala Medical College Hospital Gujranwala Punjab

Sponsors (1)

Lead Sponsor Collaborator
Gujranwala medical college District Headquarters Hospital, Gujranwala

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Allescher HD, Neuhaus H, Hagenmuller F, Classen M. Effect of N-butylscopolamine on sphincter of Oddi motility in patients during routine ERCP--a manometric study. Endoscopy. 1990 Jul;22(4):160-3. doi: 10.1055/s-2007-1012829. — View Citation

Devereaux BM, Lehman GA, Fein S, Phillips S, Fogel EL, Sherman S. Facilitation of pancreatic duct cannulation using a new synthetic porcine secretin. Am J Gastroenterol. 2002 Sep;97(9):2279-81. doi: 10.1111/j.1572-0241.2002.05982.x. — View Citation

Sherman S, Lehman GA. Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy and stone removal, and endoscopic biliary and pancreatic drainage. In: Yamada T, et al. (eds.) Text book of gastroenterology. 3rd edn. Philadelphia: Lippincott, Williams & Wilkins ; 1999: 2718 - 2746

Sola-Bonada N, de Andres-Lazaro AM, Roca-Massa M, Bordas-Alsina JM, Codina-Jane C, Ribas-Sala J. [1.6% peppermint oil solution as intestinal spasmolytic in retrograde endoscopic cholangiopancreatography]. Farm Hosp. 2012 Jul-Aug;36(4):256-60. doi: 10.1016/j.farma.2011.08.003. Epub 2011 Dec 1. Spanish. — View Citation

Wehrmann T, Schmitt T, Stergiou N, Caspary WF, Seifert H. Topical application of nitrates onto the papilla of Vater: manometric and clinical results. Endoscopy. 2001 Apr;33(4):323-8. doi: 10.1055/s-2001-13687. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Shortening of CBD cannulation time To determine the effects of dexamethasone on shortening of CBD cannulation time CBD cannulation time will be calculated from the start of the procedure (0 minutes) till complete CBD cannulation has been achieved through catheter and confirmed by fluoroscopy or procedure abandoned if unsuccessful cannulation by 30 minutes.
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