Alcoholic CirrhosisNCT04245189
EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis
An observational study of Alcoholic Cirrhosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Alcohol is the common precipitating factor for both cirrhosis of liver as well as alcohol related chronic pancreatitis. However, in real life clinical setting, clinicians do not frequently see many cases of symptomatic pancreatitis in patients who present with features of cirrhosis of liver. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- Endoscopic ultrasound for detection of Chronic pancreatitis
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients attending the Hepatology unit of AIG Hospitals.
Who may be able to join
- Patients with diagnosis of ethanol related cirrhosis of liver who complains of central abdominal pain without any other identifiable cause of pain would be enrolled in the study.
Who cannot join
- Any patients with evidence of Hepatocellular carcinoma , autoimmune hepatitis related CLD, and PBC would be excluded.
- Patients any co-existent other malignancy, sepsis, pregnancy.
- An informed consent would be signed by the patient and any patient not willing to be a part of the study will be excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology Hospitals
Hyderabad, Telangana, 500089
Mithun Sharma, MD, 8790622655, drmithunsharma@gmail.com
Sundeep Lakhtakia, MD DM
About this study
Official title: EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis: Any Difference Between Alcoholic and Non-alcoholic Patients
Alcohol is the common precipitating factor for both cirrhosis of liver as well as alcohol related chronic pancreatitis. However, in real life clinical setting, clinicians do not frequently see many cases of symptomatic pancreatitis in patients who present with features of cirrhosis of liver. On the contrary, in some patients presenting with alcohol related chronic pancreatitis, evidence of cirrhosis of liver is observed on imaging without other clinical features of cirrhosis.
Read the detailed description
The data on exact incidence of chronic pancreatitis in patients with alcoholic cirrhosis is scarce and there are no data to support or refute as to whether the incidence is same between alcoholic cirrhosis or cirrhosis due to any other cause. The co-existence of cirrhosis and chronic pancreatitis in alcoholics vary between 0.04 - 6%.
However, till now no study has been conducted to evaluate the incidence of CP in patients with alcoholic cirrhosis of liver. In this study, the investigators propose to assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis and hepatitis B and C related liver cirrhosis. This would be one of the few studies till date, to use EUS as the diagnostic modality.
The patients of cirrhosis would be categorized based on their Child Pugh criteria into three categories. All these patients would undergo EUS at the Institute and chronic pancreatitis screening would be considered positive if they fulfill the Rosemont criteria for chronic pancreatitis.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- Endoscopic ultrasound for detection of Chronic pancreatitis
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound for detection of Chronic pancreatitisOther
Presence of Chronic pancreatitis in alcoholic cirrhosis patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria .
To assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis, hepatitis B and C related liver cirrhosis.
Measured: 3 days
Secondary outcomes (2)
Assessment of Pain.
Visual Analogue Scale (VAS) measures pain intensity based on observer assessment on a scale from 1 to 10, where higher values indicate more intense pain.
Measured: 3 days
Pancreatic duct size.
In patients found to have Chronic pancreatitis -Pancreatic duct size would be assessed.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mithun Sharma, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245189
- Sponsor's protocol ID
- AIG-G-EUSCP
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stevens T, Parsi MA. Endoscopic ultrasound for the diagnosis of chronic pancreatitis. World J Gastroenterol. 2010 Jun 21;16(23):2841-50. doi: 10.3748/wjg.v16.i23.2841.
PubMed 20556829Catalano MF, Sahai A, Levy M, Romagnuolo J, Wiersema M, Brugge W, Freeman M, Yamao K, Canto M, Hernandez LV. EUS-based criteria for the diagnosis of chronic pancreatitis: the Rosemont classification. Gastrointest Endosc. 2009 Jun;69(7):1251-61. doi: 10.1016/j.gie.2008.07.043. Epub 2009 Feb 24.
PubMed 19243769Aparisi L, Sabater L, Del-Olmo J, Sastre J, Serra MA, Campello R, Bautista D, Wassel A, Rodrigo JM. Does an association exist between chronic pancreatitis and liver cirrhosis in alcoholic subjects? World J Gastroenterol. 2008 Oct 28;14(40):6171-9. doi: 10.3748/wjg.14.6171.
PubMed 18985807
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Based Prevalence of Chronic Pancreatitis in Alcoholic Cirrhosis: Any Difference Between Alcoholic and Non-alcoholic Patients
- ClinicalTrials.gov ID
- NCT04245189
- Acronym / sponsor ID
- AIG-G-EUSCP
- Conditions
- Alcoholic Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
Alcohol is the common precipitating factor for both cirrhosis of liver as well as alcohol related chronic pancreatitis. However, in real life clinical setting, clinicians do not frequently see many cases of symptomatic pancreatitis in patients who present with features of cirrhosis of liver. On the contrary, in some patients presenting with alcohol related chronic pancreatitis, evidence of cirrhosis of liver is observed on imaging without other clinical features of cirrhosis.
Detailed description
The data on exact incidence of chronic pancreatitis in patients with alcoholic cirrhosis is scarce and there are no data to support or refute as to whether the incidence is same between alcoholic cirrhosis or cirrhosis due to any other cause. The co-existence of cirrhosis and chronic pancreatitis in alcoholics vary between 0.04 - 6%.
However, till now no study has been conducted to evaluate the incidence of CP in patients with alcoholic cirrhosis of liver. In this study, the investigators propose to assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis and hepatitis B and C related liver cirrhosis. This would be one of the few studies till date, to use EUS as the diagnostic modality.
The patients of cirrhosis would be categorized based on their Child Pugh criteria into three categories. All these patients would undergo EUS at the Institute and chronic pancreatitis screening would be considered positive if they fulfill the Rosemont criteria for chronic pancreatitis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients attending the Hepatology unit of AIG Hospitals.
Key inclusion criteria (1 listed)
- Patients with diagnosis of ethanol related cirrhosis of liver who complains of central abdominal pain without any other identifiable cause of pain would be enrolled in the study.
Key exclusion criteria (3 listed)
- Any patients with evidence of Hepatocellular carcinoma , autoimmune hepatitis related CLD, and PBC would be excluded.
- Patients any co-existent other malignancy, sepsis, pregnancy.
- An informed consent would be signed by the patient and any patient not willing to be a part of the study will be excluded.
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 ultrasound for detection of Chronic pancreatitisPresence of Chronic pancreatitis in alcoholic cirrhosis patients. | Other | – |
Primary outcome
Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria .
Time frame: 3 days
To assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis, hepatitis B and C related liver cirrhosis.
2 secondary outcomes
Assessment of Pain.
Time frame: 3 days
Pancreatic duct size.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 20556829Stevens T, Parsi MA. Endoscopic ultrasound for the diagnosis of chronic pancreatitis. World J Gastroenterol. 2010 Jun 21;16(23):2841-50. doi: 10.3748/wjg.v16.i23.2841.
- Background: PubMed 19243769Catalano MF, Sahai A, Levy M, Romagnuolo J, Wiersema M, Brugge W, Freeman M, Yamao K, Canto M, Hernandez LV. EUS-based criteria for the diagnosis of chronic pancreatitis: the Rosemont classification. Gastrointest Endosc. 2009 Jun;69(7):1251-61. doi: 10.1016/j.gie.2008.07.043. Epub 2009 Feb 24.
- Background: PubMed 18985807Aparisi L, Sabater L, Del-Olmo J, Sastre J, Serra MA, Campello R, Bautista D, Wassel A, Rodrigo JM. Does an association exist between chronic pancreatitis and liver cirrhosis in alcoholic subjects? World J Gastroenterol. 2008 Oct 28;14(40):6171-9. doi: 10.3748/wjg.14.6171.
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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.
Mithun Sharma principal investigator
AIG Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Cirrhosis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 3 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 26 Jan 2021. 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 India. 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 Mithun Sharma, MD (08790622655, drmithunsharma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic pancreatitis in alcoholic cirrhotics as per Rosemont criteria . (time frame: 3 days). 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 NCT04245189, which also lists 3 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 26 Jan 2021.