Pancreatic Ductal AdenocarcinomaSIPUPNCT03770117
Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
An observational study of Pancreatic Ductal Adenocarcinoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Prehabilitation and Standard Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2018to 1 Jul 2019
- 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 16 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who have had a pancreatoduodenectomy. Control group will have had standard care and these CT Scan results will be compared with those who have undergone prehabilitation.
Who may be able to join
- Patients treated by pancreatic resection
- Surgery for malignancy
- Patients aged over 16
- CT scans available for assessment
Who cannot join
- Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway
- Aged under 16
- Patients not undergoing pancreatic resection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, Gtr Manchester, M13 9WL
About this study
Official title: A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.
Read the detailed description
Cachexia is a hallmark feature of pancreatic cancer. Patients with features of cachexia have worse clinical outcomes. This includes a reduction in quality of life, reduced tolerance of therapy and a poorer prognosis . Specifically related to patients undergoing pancreatic surgery clinical evidence of cachexia is associated with higher perioperative complication rates. Sarcopenia, defined as a decreased muscle mass independent of fat mass, is a feature of the cachexia associated with pancreatic cancer. Patients with sarcopenia have progressive and generalised reduced muscle mass and function In patients undergoing surgery for pancreatic cancer sarcopenia has been associated with increased rates of complication and worse survival . Treatment of sarcopenia is difficult but includes nutritional support and pancreatic enzyme replacement therapy (PERT) aimed at reducing malabsorption. Whether measures aimed at combating sarcopenia can improve clinical outcomes following pancreatic surgery is currently unknown.
Prehabilitation is a multimodal therapeutic regimen aimed at improving the overall physical condition of patients prior to surgery with the intention of reducing the incidence of perioperative complications. Emerging evidence suggests that exercise prior to surgery for high risk patients scheduled to undergo major abdominal surgery improves aerobic capacity and can reduce the incidence of perioperative complications . The impact of prehabilitation undertaken prior to pancreatic surgery on perioperative complication rates has not yet been investigated.
The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Prehabilitation, Standard Procedure
- Keywords
- Pancreas, Cancer, Sarcopenia, Cachexia, Prehabilitation, Pancreatoduodenectomy
- Medical subject headings
- Neoplasms, Sarcopenia, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationProcedure or surgery
Participants who underwent Prehabilitation will have their CT scans analysed.
Standard ProcedureProcedure or surgery
Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | In this arm of the study, participants will undergo prehabilitation prior to surgery. This is intended to increase the participants overall health prior to surgery to try and increase their general well-being during and after surgery.
Prehabilitation is multimodal therapy comprising:
1. Assessment for malnutrition and nutritional support dependent on the outcome
2. Optimisation of management of pancreatic exocrine insufficiency
3. Assessment of muscle mass and strength
4. Individually tailored, goal directed exercise regimen under the care of physiotherapy Receives: Procedure: Prehabilitation | |
| Standard Procedure | In this arm, participants will not receive any Rehabilitation prior to the surgery. This is the current standard care and will act as the control data for this study. Receives: Procedure: Standard Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT Scan Comparison
CT Scans from patients which underwent the Prehabilitation \& standard care will be compared.
Measured: Within last 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start4 Oct 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Saurabh Jamdar, Study chair, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770117
- Sponsor's protocol ID
- B00101
- Acronym
- SIPUP
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2018
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
- ClinicalTrials.gov ID
- NCT03770117
- Acronym / sponsor ID
- SIPUP / B00101
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreas, Cancer, Sarcopenia, Cachexia, Prehabilitation, Pancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 10 Dec 2018 (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 assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.
Detailed description
Cachexia is a hallmark feature of pancreatic cancer. Patients with features of cachexia have worse clinical outcomes. This includes a reduction in quality of life, reduced tolerance of therapy and a poorer prognosis . Specifically related to patients undergoing pancreatic surgery clinical evidence of cachexia is associated with higher perioperative complication rates. Sarcopenia, defined as a decreased muscle mass independent of fat mass, is a feature of the cachexia associated with pancreatic cancer. Patients with sarcopenia have progressive and generalised reduced muscle mass and function In patients undergoing surgery for pancreatic cancer sarcopenia has been associated with increased rates of complication and worse survival . Treatment of sarcopenia is difficult but includes nutritional support and pancreatic enzyme replacement therapy (PERT) aimed at reducing malabsorption. Whether measures aimed at combating sarcopenia can improve clinical outcomes following pancreatic surgery is currently unknown.
Prehabilitation is a multimodal therapeutic regimen aimed at improving the overall physical condition of patients prior to surgery with the intention of reducing the incidence of perioperative complications. Emerging evidence suggests that exercise prior to surgery for high risk patients scheduled to undergo major abdominal surgery improves aerobic capacity and can reduce the incidence of perioperative complications . The impact of prehabilitation undertaken prior to pancreatic surgery on perioperative complication rates has not yet been investigated.
The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | – | Procedure: PrehabilitationIn this arm of the study, participants will undergo prehabilitation prior to surgery. This is intended to increase the participants overall health prior to surgery to try and increase their general well-being during and after surgery. Prehabilitation is multimodal therapy comprising: 1. Assessment for malnutrition and nutritional support dependent on the outcome 2. Optimisation of management of pancreatic exocrine insufficiency 3. Assessment of muscle mass and strength 4. Individually tailored, goal directed exercise regimen under the care of physiotherapy |
| Standard Procedure | – | Procedure: Standard ProcedureIn this arm, participants will not receive any Rehabilitation prior to the surgery. This is the current standard care and will act as the control data for this study. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have had a pancreatoduodenectomy. Control group will have had standard care and these CT Scan results will be compared with those who have undergone prehabilitation.
Key inclusion criteria (4 listed)
- Patients treated by pancreatic resection
- Surgery for malignancy
- Patients aged over 16
- CT scans available for assessment
Key exclusion criteria (3 listed)
- Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway
- Aged under 16
- Patients not undergoing pancreatic resection
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 |
|---|---|---|
| PrehabilitationParticipants who underwent Prehabilitation will have their CT scans analysed. | Procedure or surgery | Prehabilitation |
| Standard ProcedurePatients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared. | Procedure or surgery | Standard Procedure |
Primary outcome
CT Scan Comparison
Time frame: Within last 5 years.
CT Scans from patients which underwent the Prehabilitation \& standard care will be compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Saurabh Jamdar study chair
Manchester University NHS Foundation Trust
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 Pancreatic Ductal Adenocarcinoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 19 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CT Scan Comparison (time frame: Within last 5 years.). 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 19 Jan 2021.