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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

Browse trials for

Keywords

  • ERCP, Steroids, Dexamethasone, CBD cannulation time
03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's enrollment of 80 is below the median of 98 across 121 interventional studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Gujranwala medical college District Headquarters Hospital, Gujranwala is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 like DM
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

  • 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

06

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.

07

Study locations

1 site
  • Gujranwala Medical College Hospital
    Gujranwala, Punjab 52070, Pakistan
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Apr 2024, 8 months.

Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 8 months is below that.

Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2023
First posted
Jul 14, 2023
StartActual
Aug 1, 2023
Primary completionActual
Apr 12, 2024
CompletionActual
May 16, 2024
Last update
Mar 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drug tested here: Dexamethasone

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