Effects of Dexamethasone on Common Bile Duct Cannulation Time

NCT05945797 | Completed DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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 4mg DRUG

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 Arm; NS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• 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

Sponsors & Collaborators

• Gujranwala medical college District Headquarters Hospital, Gujranwala: lead

Study Sites (1)

Gujranwala Medical College Hospital

Gujranwala, Punjab Province, 52070, Pakistan

Location

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: 11315893 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22137159 BACKGROUND

• 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.

  PMID: 12358245 BACKGROUND

MeSH Terms

Conditions

Common Bile Duct Diseases; Gallstones; Common Bile Duct Neoplasms

Interventions

Dexamethasone; Steroids

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bile Duct Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Najam us Sehar Saeed, FCPS-Gastro

  GMC-DHQ Hospital, Gujwanala, Pakistan

  STUDY CHAIR

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
• Primary Completion: April 12, 2024
• Study Completion: May 16, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)