Clinical trial NCT05945797: Effects of Dexamethasone on Common Bile Duct Cannulation Time
Official title: Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography Be Shortened by Dexamethasone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Diseases
Common Bile Duct Calculi
Common Bile Duct Stricture
Common Bile Duct Neoplasms
Common Bile Duct Dilatation
Keywords: ERCP, Steroids, Dexamethasone, CBD cannulation time
Lead sponsor: Gujranwala medical college District Headquarters Hospital, Gujranwala
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shortening of CBD cannulation time
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Gujranwala
country: Pakistan
facility: Gujranwala Medical College Hospital
state: Punjab
Study officials:
affiliation: GMC-DHQ Hospital, Gujwanala, Pakistan
name: Najam us Sehar Saeed, FCPS-Gastro
role: STUDY_CHAIR
References:
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
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.
citation: 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.
citation: 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.
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.