Obstructive JaundiceNCT06093048
Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome
A study testing Endoscopic retrograde cholangiopancreatography in people with Obstructive Jaundice, run by Sohag University at 1 site in Egypt.
Trial summary
The incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Jaundice
- What is being tested?
- Endoscopic retrograde cholangiopancreatography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2023to Oct 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
- patients with obstructive jaundice older than 18 years old
Who cannot join
- patients who refuse consent
- patients under 18 years old
Trial locations and contacts
1 site in 1 country.
Hassan A Hassanein, professor contact
About this study
The incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders.
In general, old age is defined as being more than 65 years of age by the World Health Organization. The increase in the domestic aged population is related to the increasing demand for therapeutic ERCP in elderly patients with pancreato-biliary disorders. Common bile duct stones and cancer account for70 % of all jaundice cases in patients over the age of 65 years . This is related to increasing prevalences of cholelithiasis, choledocholithiasis, and malignancy with advancing age .
Endoscopic Retrograde Cholangiopancreatography(ERCP) represents the gold standard technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.
Read the detailed description
However, therapeutic ERCP is an invasive procedure and is associated with several complications, such as bleeding, pancreatitis, cholangitis, perforation, and mortality. A higher incidence of periprocedural complications might be expected in elderly patients because of the high prevalence of concomitant medical disorders, such as cardiopulmonary and cerebrovascular diseases, and the poor general condition of this population [8].
Despite many previous reports of the safety and efficacy of ERCP in elderly patients, in real clinical practice, there is concern regarding complications of ERCP performed in patients more than 65years old. Also comparative reports of the efficacy and safety of therapeutic ERCP, especially inpatients over 65 years of age, are limited. To investigate this issue, we will evaluate the clinical outcomes such as the technical success rate, procedure-related complications rate, and anesthesia-related adverse events rate of therapeutic ERCP in a older aged group (over than 65 years of age) and control group (less than 65 years of age) at a single tertiary center.
Aim of the work This study aims to evaluate the outcome and safety of ERCP in patients with obstructive jaundice over than 65 years of age.
- Conditions
- Obstructive Jaundice
- Being tested
- Endoscopic retrograde cholangiopancreatography
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatographyProcedure or surgery
saftey and outcome in patients older than 65 years old
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | patients with obstructive jaundice equal or older than 65 years old Receives: Procedure: Endoscopic retrograde cholangiopancreatography |
| group B | Active comparator | patients with obstructive jaundice younger than 65 years old Receives: Procedure: Endoscopic retrograde cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatitis
serum amylase and lipase using Mann Whitney test
Measured: 12 months
Cholangitis
Temperature chart and serum bilirubin using Chi-square test
Measured: 12 months
Secondary outcomes (1)
Technical success rate
procedure time and frequency of a second ERCP for complete success.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ezzat Mahmoud, Sohag University
- Investigators
- Mohamed E Mahmoud, Specialist, Study director, Sohag UniversityMohamed E Mahmoud, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093048
- Sponsor's protocol ID
- Soh-Med-23-10-07MD
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang ZM, Liu Z, Liu LM, Zhang C, Yu HW, Wan BJ, Deng H, Zhu MW, Liu ZX, Wei WP, Song MM, Zhao Y. Therapeutic experience of 289 elderly patients with biliary diseases. World J Gastroenterol. 2017 Apr 7;23(13):2424-2434. doi: 10.3748/wjg.v23.i13.2424.
PubMed 28428722Ukkonen M, Siiki A, Antila A, Tyrvainen T, Sand J, Laukkarinen J. Safety and Efficacy of Acute Endoscopic Retrograde Cholangiopancreatography in the Elderly. Dig Dis Sci. 2016 Nov;61(11):3302-3308. doi: 10.1007/s10620-016-4283-2. Epub 2016 Aug 26.
PubMed 27565508Perisetti A, Goyal H, Sharma N. Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP). Endosc Int Open. 2022 Apr 14;10(4):E558-E561. doi: 10.1055/a-1747-3242. eCollection 2022 Apr.
PubMed 35433228Holt BA. Increased severity of post-endoscopic retrograde cholangiopancreatography complications in the elderly: an issue to be addressed. Dig Endosc. 2014 Jul;26(4):534-5. doi: 10.1111/den.12298. No abstract available.
PubMed 25040209
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome
- ClinicalTrials.gov ID
- NCT06093048
- Acronym / sponsor ID
- Soh-Med-23-10-07MD
- Conditions
- Obstructive Jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 23 Oct 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 incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders.
In general, old age is defined as being more than 65 years of age by the World Health Organization. The increase in the domestic aged population is related to the increasing demand for therapeutic ERCP in elderly patients with pancreato-biliary disorders. Common bile duct stones and cancer account for70 % of all jaundice cases in patients over the age of 65 years . This is related to increasing prevalences of cholelithiasis, choledocholithiasis, and malignancy with advancing age .
Endoscopic Retrograde Cholangiopancreatography(ERCP) represents the gold standard technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.
Detailed description
However, therapeutic ERCP is an invasive procedure and is associated with several complications, such as bleeding, pancreatitis, cholangitis, perforation, and mortality. A higher incidence of periprocedural complications might be expected in elderly patients because of the high prevalence of concomitant medical disorders, such as cardiopulmonary and cerebrovascular diseases, and the poor general condition of this population [8].
Despite many previous reports of the safety and efficacy of ERCP in elderly patients, in real clinical practice, there is concern regarding complications of ERCP performed in patients more than 65years old. Also comparative reports of the efficacy and safety of therapeutic ERCP, especially inpatients over 65 years of age, are limited. To investigate this issue, we will evaluate the clinical outcomes such as the technical success rate, procedure-related complications rate, and anesthesia-related adverse events rate of therapeutic ERCP in a older aged group (over than 65 years of age) and control group (less than 65 years of age) at a single tertiary center.
Aim of the work This study aims to evaluate the outcome and safety of ERCP in patients with obstructive jaundice over than 65 years of age.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Endoscopic retrograde cholangiopancreatographypatients with obstructive jaundice equal or older than 65 years old |
| group B | Active comparator | Procedure: Endoscopic retrograde cholangiopancreatographypatients with obstructive jaundice younger than 65 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with obstructive jaundice older than 18 years old
Key exclusion criteria (2 listed)
- patients who refuse consent
- patients under 18 years old
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 |
|---|---|---|
| Endoscopic retrograde cholangiopancreatographysaftey and outcome in patients older than 65 years old | Procedure or surgery | group A, group B |
Primary outcome
Pancreatitis
Time frame: 12 months
serum amylase and lipase using Mann Whitney test
Cholangitis
Time frame: 12 months
Temperature chart and serum bilirubin using Chi-square test
1 secondary outcome
Technical success rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 28428722Zhang ZM, Liu Z, Liu LM, Zhang C, Yu HW, Wan BJ, Deng H, Zhu MW, Liu ZX, Wei WP, Song MM, Zhao Y. Therapeutic experience of 289 elderly patients with biliary diseases. World J Gastroenterol. 2017 Apr 7;23(13):2424-2434. doi: 10.3748/wjg.v23.i13.2424.
- Background: PubMed 27565508Ukkonen M, Siiki A, Antila A, Tyrvainen T, Sand J, Laukkarinen J. Safety and Efficacy of Acute Endoscopic Retrograde Cholangiopancreatography in the Elderly. Dig Dis Sci. 2016 Nov;61(11):3302-3308. doi: 10.1007/s10620-016-4283-2. Epub 2016 Aug 26.
- Background: PubMed 35433228Perisetti A, Goyal H, Sharma N. Clinical safety and outcomes of glucagon use during endoscopic retrograde cholangiopancreatography (ERCP). Endosc Int Open. 2022 Apr 14;10(4):E558-E561. doi: 10.1055/a-1747-3242. eCollection 2022 Apr.
- Background: PubMed 25040209Holt BA. Increased severity of post-endoscopic retrograde cholangiopancreatography complications in the elderly: an issue to be addressed. Dig Endosc. 2014 Jul;26(4):534-5. doi: 10.1111/den.12298. No abstract available.
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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.
Hassan A Hassanein, professor contact
Mohamed E Mahmoud, Specialist study director
Sohag University
Mohamed E Mahmoud study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic retrograde cholangiopancreatography in people with Obstructive Jaundice, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed E mahmoud, spcialist (01280711516, mohamed.hassan4@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatitis (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06093048, which also lists 4 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 31 Oct 2023.