Benign or Malignant Liver and Bile Duct DiseaseNCT04637243
Outcomes From Treatment Liver and Bile Duct Diseases
An observational study of Benign or Malignant Liver and Bile Duct Disease, run by Methodist Health System at 1 site in United States.
Trial summary
It is reported in the literature that the treatment of any liver and bile duct disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign or Malignant Liver and Bile Duct Disease
- What is being tested?
- Treatment of Benign or Malignant Liver and Bile Duct Diseases
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X.
Who may be able to join
- All patients diagnosed and treated for liver and bile duct disease benign or malignant from 2005 to present (up to the day before this study receives IRB approval)
- Age > 18 years
Who cannot join
- Patients that are not diagnosed with or treated for liver and bile duct disease
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Richardson Medical Center
Richardson, Texas, 75082
About this study
Official title: Evaluation of Outcomes From Treatment of Benign or Malignant Liver and Bile Duct Diseases
It is reported in the literature that the treatment of any liver and bile duct disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. Our goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity.
The main aim of this study is to evaluate and compare the outcomes from our multiple treatments of benign or malignant liver and bile duct diseases.
Read the detailed description
The study will be a retrospective chart review of patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X. We plan to conduct an analysis of patients meeting the inclusion criteria form 2005 to present (up to the day before this study receives IRB approval). Charts will also be reviewed by the PI. Sub-I, Fellows, Office Staff, Clinical Research Coordinator who are delegated to do so by the PI. Data will be obtained from a national database. Data will be analyzed primarily by the study conductors.
- Being tested
- Treatment of Benign or Malignant Liver and Bile Duct Diseases
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Benign or Malignant Liver and Bile Duct DiseasesOther
Available treatment of Benign or Malignant Liver and Bile Duct Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases
Mortality
Measured: 2005 to 2019
Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases
Morbidity
Measured: 2005 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start9 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign or Malignant Liver and Bile Duct DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhiresh Jeyarajah, M.D., Principal investigator, Trinity Surgical Consultants, Methodist Richardson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637243
- Sponsor's protocol ID
- 035.HPB.2018.R
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes From Treatment of Benign or Malignant Liver and Bile Duct Diseases
- ClinicalTrials.gov ID
- NCT04637243
- Acronym / sponsor ID
- 035.HPB.2018.R
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 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.
It is reported in the literature that the treatment of any liver and bile duct disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. Our goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity.
The main aim of this study is to evaluate and compare the outcomes from our multiple treatments of benign or malignant liver and bile duct diseases.
Detailed description
The study will be a retrospective chart review of patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X. We plan to conduct an analysis of patients meeting the inclusion criteria form 2005 to present (up to the day before this study receives IRB approval). Charts will also be reviewed by the PI. Sub-I, Fellows, Office Staff, Clinical Research Coordinator who are delegated to do so by the PI. Data will be obtained from a national database. Data will be analyzed primarily by the study conductors.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been diagnosed with benign or malignant liver and bile duct disease under the practices of Rohan Jeyarajah, M.D., Houssam Osman, M.D., F.A.C.S., Edward Cho, M.D., Sc.M at Methodist Health System Hospital in Richardson, T.X.
Key inclusion criteria (2 listed)
- All patients diagnosed and treated for liver and bile duct disease benign or malignant from 2005 to present (up to the day before this study receives IRB approval)
- Age > 18 years
Key exclusion criteria (2 listed)
- Patients that are not diagnosed with or treated for liver and bile duct disease
- Age < 18 years
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 |
|---|---|---|
| Treatment of Benign or Malignant Liver and Bile Duct DiseasesAvailable treatment of Benign or Malignant Liver and Bile Duct Diseases | Other | – |
Primary outcome
Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases
Time frame: 2005 to 2019
Mortality
Morbidity from Treatment of Benign or Malignant Liver and Bile Duct Diseases
Time frame: 2005 to 2019
Morbidity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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.
Dhiresh Jeyarajah, M.D. principal investigator
Trinity Surgical Consultants, Methodist Richardson Medical Center
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 Benign or Malignant Liver and Bile Duct Disease, run by Methodist Health System at 1 site in United States.
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 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality from Treatment of Benign or Malignant Liver and Bile Duct Diseases (time frame: 2005 to 2019). 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?
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 10 Jun 2026.