SurgeryNCT05128890
Evaluation of Resection Techniques for Pancreatic Tumors
An observational study of Surgery and Liver Tumor, run by Methodist Health System at 1 site in United States.
Trial summary
The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Liver Tumor, Pancreas Tumor
- What is being tested?
- Resection techniques for pancreatic and liver tumors
- Type of treatment
- Surgery or procedure
- How many people
- 431 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2016to 26 Apr 2027
- 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: pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
Who may be able to join
- Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
- Patients 18 years old or older
Who cannot join
- Patients that have not undergone pancreatic resection surgeries
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette N Ndjom, MS, (214) 947-4681 ext. 71280, mhsirb@mhd.com
Jennifer Kirchner, 214-947-4459 ext. 74459, jenniferkirchner@mhd.com
About this study
The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint.
The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.
Read the detailed description
The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.
- Conditions
- Surgery, Liver Tumor, Pancreas Tumor
- Being tested
- Resection techniques for pancreatic and liver tumors
- Medical subject headings
- Carcinoma, Hepatocellular, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection techniques for pancreatic and liver tumorsProcedure or surgery
Also called minimally invasive pancreatic resection techniques
to compare open versus minimally invasive pancreatic resection techniques and analyze the different outcome variables from the clinical standpoint
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
It will be calculated in days.Minimally invasive techniques are being adopted for complex pancreatic and liver surgery and there is a need to understand if these techniques are advantageous to the patient, if the cost is justified and if the risks are acceptable when compared to the gold standard open surgery.
Measured: through study completion, an average of 1 year
Length of stay
It will be calculated in days. The days stayed in hospital post-procedure.
Measured: Up to 1 year
Complication rates
Patient may visit physician or hospital for any symptoms or may need hospitalizations.
Measured: through study completion, an average of 1 year
Operative time
The time required for the procedure.
Measured: up to 10 hours
Transfusion rate
If any post-procedure transfusion required, will be recorded.
Measured: through study completion, an average of 1 year
30 and 90 day readmission rate
After the procedure any hospital admissions up to 30 days will be recorded.
Measured: through study completion, an average of 1 year
Hospital charges
The hospital charges for the procedure will be recorded.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start16 Apr 2016
- Primary completion26 Apr 2027 (estimated)
- Study completion26 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- 431 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, M.D., Principal investigator, The Liver Institute, Methodist Dallas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128890
- Sponsor's protocol ID
- 028.HPB.2016.D
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2019
- Last updated
- 20 Mar 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resection Techniques for Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT05128890
- Acronym / sponsor ID
- 028.HPB.2016.D
- Conditions
- Surgery, Liver Tumor, Pancreas Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 431 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 22 Nov 2021 (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 objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint.
The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.
Detailed description
The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.
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
- pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
Key inclusion criteria (2 listed)
- Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
- Patients 18 years old or older
Key exclusion criteria (2 listed)
- Patients that have not undergone pancreatic resection surgeries
- Patients under 18 years of age
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 |
|---|---|---|
| Resection techniques for pancreatic and liver tumorsAlso: minimally invasive pancreatic resection techniquesto compare open versus minimally invasive pancreatic resection techniques and analyze the different outcome variables from the clinical standpoint | Procedure or surgery | – |
Primary outcome
Patient Survival
Time frame: through study completion, an average of 1 year
It will be calculated in days.Minimally invasive techniques are being adopted for complex pancreatic and liver surgery and there is a need to understand if these techniques are advantageous to the patient, if the cost is justified and if the risks are acceptable when compared to the gold standard open surgery.
Length of stay
Time frame: Up to 1 year
It will be calculated in days. The days stayed in hospital post-procedure.
Complication rates
Time frame: through study completion, an average of 1 year
Patient may visit physician or hospital for any symptoms or may need hospitalizations.
Operative time
Time frame: up to 10 hours
The time required for the procedure.
Transfusion rate
Time frame: through study completion, an average of 1 year
If any post-procedure transfusion required, will be recorded.
30 and 90 day readmission rate
Time frame: through study completion, an average of 1 year
After the procedure any hospital admissions up to 30 days will be recorded.
Hospital charges
Time frame: through study completion, an average of 1 year
The hospital charges for the procedure will be recorded.
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 20 Mar 2026.
- 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.
Alejandro Mejia, M.D. principal investigator
The Liver Institute, Methodist Dallas 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 Surgery and Liver Tumor, 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: looking for participants now, as of the sponsor's last update on 20 Mar 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?
Contact Colette N Ndjom, MS (214-947-4681 ext. 74681, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: through study completion, an average of 1 year). The study lists 7 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 20 Mar 2026.