Effects of Dexamethasone on Common Bile Duct Cannulation Time

NCT ID: NCT05945797

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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Common Bile Duct Diseases Common Bile Duct Calculi Common Bile Duct Stricture Common Bile Duct Neoplasms Common Bile Duct Dilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexa Arm

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

Group Type EXPERIMENTAL

Dexamethasone 4mg

Intervention Type DRUG

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

NS Arm

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

Group Type PLACEBO_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

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

Interventions

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Dexamethasone 4mg

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

Intervention Type DRUG

Other Intervention Names

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steroids

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gujranwala medical college District Headquarters Hospital, Gujranwala

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Najam us Sehar Saeed, FCPS-Gastro

Role: STUDY_CHAIR

GMC-DHQ Hospital, Gujwanala, Pakistan

Locations

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Gujranwala Medical College Hospital

Gujranwala, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11315893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2209497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22137159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12358245 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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