Effects of Dexamethasone on Common Bile Duct Cannulation Time

Common Bile Duct Calculi Clinical Trial

Official title:

Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945797
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Bile Duct Neoplasms
• Calculi
• Common Bile Duct Calculi
• Common Bile Duct Diseases
• Common Bile Duct Neoplasms
• Common Bile Duct Stricture
• Gallstones

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.