Pancreatic NeoplasmsNCT05489419
Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
A study testing Multimodal Prehabilitation in people with Pancreatic Neoplasms and Anesthesia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasms, Anesthesia
- What is being tested?
- Multimodal Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 30 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients eligible for pancreatic surgery (PD) who are considered high risk based on the findings of the CPET (anaerobic threshold, AU <11ml/kg/min) (Older P et al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the multidisciplinary committee of our Institution.
Who cannot join
- Non-elective surgery;
- Palliative surgery;
- Unstable respiratory or cardiac disease;
- Locomotor or cognitive limitations that prevent adherence to the program;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Carol González, MD, +34638725100, carol.gonzaleza@clinic.cat
About this study
Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.
Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.
Read more
Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:
- Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
- Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
- Treatment of anxiety and depression.
Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.
Analysis:
The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.
- Conditions
- Pancreatic Neoplasms, Anesthesia
- Being tested
- Multimodal Prehabilitation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationBehavioural
Physical and cardiopulmonary training, personalized nutrition and treatment of anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Patients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery. Receives: Behavioral: Multimodal Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a multimodal prehabilitation
To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET.
Measured: 4 weeks
Secondary outcomes (6)
Evaluation of the adherence to the program
Assess the % of sessions that the patient has completed
Measured: 30 days
Evaluation of sarcopenia after prehabilitation
Sarcopenia analyzed objectively with a CT scan.
Measured: 4 weeks
Evaluation of the impact on perceived quality of life
Evaluation of the impact of the program in patient quality of life according EuroQol (Qual Life Res. 1999 ;8:303-10)
Measured: 4 weeks
Evaluation of the impact on the inflammatory response after the intervention
Presence or abscence of Systemic Inflammatory Response Syndrome (SIRS) during the preoperative period. SIRS defined by two of the following criteria: Body temperature over 38 or under 36 degrees Celsius.
Heart rate greater than 90 beats/minute Respiratory rate greater than 20 breaths/minute or partial pressure of CO2 less than 32 mmHg Leucocyte count greater than 12000 or less than 4000 /microliters or over 10% immature forms or bands.
Measured: 30 days
Evaluation of the impact on the incidence of postoperative complications
Incidence of complications
Measured: 30 days
Evaluation of complications severity
Complications according Clavien-Dindo Classification
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Jan 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489419
- Sponsor's protocol ID
- HCB/2020/0477
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 5 Aug 2022
- 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
- ClinicalTrials.gov ID
- NCT05489419
- Acronym / sponsor ID
- HCB/2020/0477
- Conditions
- Pancreatic Neoplasms, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 5 Aug 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.
Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.
Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.
Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:
- Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
- Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
- Treatment of anxiety and depression.
Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.
Analysis:
The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Multimodal PrehabilitationPatients undergo prehabilitation during 3-4 weeks before undergoing pancreatic surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients eligible for pancreatic surgery (PD) who are considered high risk based on the findings of the CPET (anaerobic threshold, AU <11ml/kg/min) (Older P et al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the multidisciplinary committee of our Institution.
Key exclusion criteria (5 listed)
- Non-elective surgery;
- Palliative surgery;
- Unstable respiratory or cardiac disease;
- Locomotor or cognitive limitations that prevent adherence to the program;
- Refusal to participate in the study.
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 |
|---|---|---|
| Multimodal PrehabilitationPhysical and cardiopulmonary training, personalized nutrition and treatment of anxiety and depression. | Behavioural | Prehabilitation |
Primary outcome
Efficacy of a multimodal prehabilitation
Time frame: 4 weeks
To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET.
6 secondary outcomes
Evaluation of the adherence to the program
Time frame: 30 days
Evaluation of sarcopenia after prehabilitation
Time frame: 4 weeks
Evaluation of the impact on perceived quality of life
Time frame: 4 weeks
Evaluation of the impact on the inflammatory response after the intervention
Time frame: 30 days
Evaluation of the impact on the incidence of postoperative complications
Time frame: 30 days
Evaluation of complications severity
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation in people with Pancreatic Neoplasms and Anesthesia, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 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 5 Aug 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 Spain. 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 Carol González, MD (+34638725100, carol.gonzaleza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a multimodal prehabilitation (time frame: 4 weeks). 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 5 Aug 2022.