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CompletedNCT05945797Updated Mar 21, 2025

Effects of Dexamethasone on Common Bile Duct Cannulation Time

An interventional study of Dexamethasone 4mg in Common Bile Duct Diseases, Common Bile Duct Calculi and Common Bile Duct Stricture, sponsored by Gujranwala medical college District Headquarters Hospital, Gujranwala. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Gujranwala medical college District Headquarters Hospital, Gujranwala · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 18 years or above
  • Both genders, male and female patients

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Dexa Arm

    Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.

    Drug: Dexamethasone 4mg

  • Placebo comparator
    NS Arm

    Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.

    Drug: Dexamethasone 4mg

Interventions

  • DrugDexamethasone 4mg

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

    Also known as: steroids

05

What researchers measure

Primary outcomes

  1. Shortening of CBD cannulation time

    To determine the effects of dexamethasone on shortening of CBD cannulation time

    Time frame: 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.

06

Study locations

1 site
  • Gujranwala Medical College Hospital
    Gujranwala, Punjab 52070, Pakistan
07

References and documents

Publications

  • 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
  • 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. PubMed 11315893 ↗
  • 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. PubMed 2209497 ↗
  • 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. PubMed 22137159 ↗
  • 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. PubMed 12358245 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05945797
Lead sponsor
Gujranwala medical college District Headquarters Hospital, Gujranwala
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Aug 1, 2023
Primary completion
Apr 12, 2024
Completion
May 16, 2024
Last update
Mar 21, 2025

Study contacts

Najam us Sehar Saeed, FCPS-Gastro
study chair · GMC-DHQ Hospital, Gujwanala, Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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