Trials Sponsors Conditions Drugs Pricing

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

Outcome Measures

Primary Outcomes (1)

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.

Study Arms (2)

Dexa Arm

EXPERIMENTAL

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

Drug: Dexamethasone 4mg

NS Arm

PLACEBO COMPARATOR

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

Drug: Dexamethasone 4mg

Interventions

Dexamethasone 4mgDrug

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

Dexa ArmNS Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Gujranwala medical college District Headquarters Hospital, Gujranwala
Otherlead

Study Sites (1)

Gujranwala Medical College Hospital

Gujranwala, Punjab Province, 52070, Pakistan

Related Publications (5)

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
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.
PMID: 11315893BACKGROUND
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.
PMID: 2209497

MeSH Terms

Conditions

Common Bile Duct DiseasesGallstonesCommon Bile Duct Neoplasms

Interventions

DexamethasoneSteroids

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Najam us Sehar Saeed, FCPS-Gastro
GMC-DHQ Hospital, Gujwanala, Pakistan
STUDY CHAIR

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 11, 2023

First Posted

July 14, 2023

Study Start

August 1, 2023

Actual (reported)

Effects of Dexamethasone on Common Bile Duct Cannulation Time

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Dexa Arm

NS Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Dexa Arm

NS Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations