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Effects of Dexamethasone on Common Bile Duct Cannulation Time

Primary Purpose

Common Bile Duct Diseases, Common Bile Duct Calculi, Common Bile Duct Stricture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone 4mg
Sponsored by
Gujranwala medical college District Headquarters Hospital, Gujranwala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Diseases focused on measuring ERCP, Steroids, Dexamethasone, CBD cannulation time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexa Arm

    NS Arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Gujranwala medical college District Headquarters Hospital, Gujranwala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05945797
    Brief Title
    Effects of Dexamethasone on Common Bile Duct Cannulation Time
    Official Title
    Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gujranwala medical college District Headquarters Hospital, Gujranwala

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexa Arm
    Arm Type
    Experimental
    Arm Description
    Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.
    Arm Title
    NS Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone 4mg
    Other Intervention Name(s)
    steroids
    Intervention Description
    An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.
    Primary Outcome Measure Information:
    Title
    Shortening of CBD cannulation time
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad Nabeel Shafqat
    Phone
    +923000426232
    Email
    nabeelshafqat89@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Najam us Sehar Saeed, FCPS-Gastro
    Organizational Affiliation
    GMC-DHQ Hospital, Gujwanala, Pakistan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    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
    Results Reference
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    PubMed Identifier
    11315893
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2209497
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22137159
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12358245
    Citation
    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.
    Results Reference
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    Effects of Dexamethasone on Common Bile Duct Cannulation Time

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