Patients Undergoing Minimally Invasive Pylorus Preserving PancreaticoduodenectomyNCT05320978
Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study
An observational study of Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy
- What is being tested?
- Hand grip test, computed tomography
- Type of treatment
- Medical device
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2022to 27 Mar 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy
Who may be able to join
- 1. patients 20 years or older who undergo minimally invasive pylorus preserving pancreaticoduodenectomy
Who cannot join
- emergency surgery
- patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
- patients with cognitive dysfunction
- pregnant, lactating women
- When hand grip test cannot be performed
- patients with atrial fibrillation, moderate or severe valvular heart disease, left ventricular ejection fraction less than 35%
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
So Yeon Kim, MD, PhD, 82-2-2228-2429, KIMSY326@yuhs.ac
About this study
The aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy.
- Being tested
- Hand grip test, computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip test, computed tomographyDevice
A hand grip test, abdominal computed tomography are performed before surgery.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing minimally invasive pylor-preserving pancreaticoduodenectomy | Adult patients aged 20 years or older and who underg minimally invasive pylor-preserving pancreaticoduodenectomy Receives: Device: Hand grip test, computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
time weighted average intraoperative hypotension
- Intraoperative hypotension is defined as a mean blood pressure < 65 mmHg.
Measured: Procedure (From the induction of anesthesia to the end of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start18 Apr 2022
- Primary completion27 Mar 2024 (estimated)
- Study completion27 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Minimally Invasive Pylorus Preserving PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- So Yeon Kim, MD,PhD, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320978
- Sponsor's protocol ID
- 4-2022-0135
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05320978
- Acronym / sponsor ID
- 4-2022-0135
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 27 Mar 2024 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 11 Apr 2022 (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 aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing minimally invasive pylor-preserving pancreaticoduodenectomy | – | Device: Hand grip test, computed tomographyAdult patients aged 20 years or older and who underg minimally invasive pylor-preserving pancreaticoduodenectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy
Key inclusion criteria (1 listed)
- 1. patients 20 years or older who undergo minimally invasive pylorus preserving pancreaticoduodenectomy
Key exclusion criteria (6 listed)
- emergency surgery
- patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
- patients with cognitive dysfunction
- pregnant, lactating women
- When hand grip test cannot be performed
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 |
|---|---|---|
| Hand grip test, computed tomographyA hand grip test, abdominal computed tomography are performed before surgery. | Device | patients undergoing minimally invasive pylor-preserving pancreaticoduodenectomy |
Primary outcome
time weighted average intraoperative hypotension
Time frame: Procedure (From the induction of anesthesia to the end of anesthesia)
1) Intraoperative hypotension is defined as a mean blood pressure < 65 mmHg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided
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.
So Yeon Kim, MD,PhD principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea.
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 Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy, run by Yonsei University at 1 site in South Korea.
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 6 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 21 Apr 2022. 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 South Korea. 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 So Yeon Kim, MD,PhD (82-2-2228-2429, KIMSY326@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time weighted average intraoperative hypotension (time frame: Procedure (From the induction of anesthesia to the end of anesthesia)). 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 21 Apr 2022.