Common Bile Duct DiseasesNCT05945797
Effects of Dexamethasone on Common Bile Duct Cannulation Time
A study testing Dexamethasone 4mg in people with Common Bile Duct Diseases and Common Bile Duct Calculi, run by Gujranwala medical college District Headquarters Hospital, Gujranwala at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Diseases, Common Bile Duct Calculi, Common Bile Duct Stricture
- What is being tested?
- Dexamethasone 4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or above
- Both genders, male and female patients
Who cannot join
- 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
Show all 9Show fewer
- Lack of competence in patients
- Roux en Y gastric bypass
- Patients with contra indications for steroids like DM
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gujranwala Medical College Hospital
Gujranwala, Punjab Province, 52070
About this study
Official title: Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography Be Shortened by Dexamethasone
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
- Being tested
- Dexamethasone 4mg
- Keywords
- ERCP, Steroids, Dexamethasone, CBD cannulation time
- Medical subject headings
- Common Bile Duct Diseases, Gallstones, Common Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mgDrug
Also called steroids
An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.
| Study group | Role | What they receive |
|---|---|---|
| Dexa Arm | Experimental | Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP. Receives: Drug: Dexamethasone 4mg |
| NS Arm | Placebo comparator | Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP. Receives: Drug: Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortening of CBD cannulation time
To determine the effects of dexamethasone on shortening of CBD cannulation time
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2023
- Primary completion12 Apr 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, Gujranwala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Najam us Sehar Saeed, FCPS-Gastro, Study chair, GMC-DHQ Hospital, Gujwanala, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945797
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 11315893Allescher 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 2209497Sola-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 22137159Devereaux 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography Be Shortened by Dexamethasone
- ClinicalTrials.gov ID
- NCT05945797
- Acronym / sponsor ID
- 001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, GujranwalaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexa Arm | Experimental | Drug: Dexamethasone 4mgExperimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP. |
| NS Arm | Placebo comparator | Drug: Dexamethasone 4mgPlacebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 years or above
- Both genders, male and female patients
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 4mgAlso: steroidsAn injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP. | Drug | Dexa Arm, NS Arm |
Primary outcome
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.
To determine the effects of dexamethasone on shortening of CBD cannulation time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- BackgroundSherman 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: PubMed 11315893Wehrmann 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.
- Background: PubMed 2209497Allescher 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.
- Background: PubMed 22137159Sola-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.
- Background: PubMed 12358245Devereaux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najam us Sehar Saeed, FCPS-Gastro study chair
GMC-DHQ Hospital, Gujwanala, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 4mg in people with Common Bile Duct Diseases and Common Bile Duct Calculi, run by Gujranwala medical college District Headquarters Hospital, Gujranwala at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945797, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.