Pancreaticobiliary CancerNCT03294096
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients
A study testing Routine care + Nutritional product and Routine care in people with Pancreaticobiliary Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreaticobiliary Cancer
- What is being tested?
- Routine care + Nutritional product and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Sep 2017to 11 Jul 2018
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age more than 19)
- Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
- Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer
Who cannot join
- Patient who denied clinical trial
- Diabetes Mellitus(DM) patient with DM complication
- Hyperlipidemia patient with vascular co-morbidity
- Impaired renal function or renal failure (GFP<70%)
- Poor nutritional status (PG-SGA grade C)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, 03722
About this study
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.
- Conditions
- Pancreaticobiliary Cancer
- Being tested
- Routine care + Nutritional product, Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care + Nutritional productDietary supplement
Routine post-op care + Nutritional supplement by specific product
Routine careOther
Routine post-op care
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Dietary Supplement: Routine care + Nutritional product |
| control group | Active comparator | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake Rate(%) for postoperative diet
Diet Intake Rate(%)
Measured: Pre-operation
Food Intake Rate(%) for postoperative diet
Diet Intake Rate(%)
Measured: 1 day before discharging
Food Intake Rate(%) for postoperative diet
Diet Intake Rate(%)
Measured: 1 week after discharging (first outpatient follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start4 Sep 2017
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreaticobiliary CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294096
- Sponsor's protocol ID
- 4-2017-0625
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2017
- Last updated
- 15 Jan 2019
- 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 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients
- ClinicalTrials.gov ID
- NCT03294096
- Acronym / sponsor ID
- 4-2017-0625
- Conditions
- Pancreaticobiliary Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 26 Sep 2017 (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.
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: Routine care + Nutritional product |
| control group | Active comparator | Other: Routine care |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age more than 19)
- Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
- Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer
Key exclusion criteria (5 listed)
- Patient who denied clinical trial
- Diabetes Mellitus(DM) patient with DM complication
- Hyperlipidemia patient with vascular co-morbidity
- Impaired renal function or renal failure (GFP<70%)
- Poor nutritional status (PG-SGA grade C)
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 |
|---|---|---|
| Routine care + Nutritional productRoutine post-op care + Nutritional supplement by specific product | Dietary supplement | experimental group |
| Routine careRoutine post-op care | Other | control group |
Primary outcome
Food Intake Rate(%) for postoperative diet
Time frame: Pre-operation
Diet Intake Rate(%)
Food Intake Rate(%) for postoperative diet
Time frame: 1 day before discharging
Diet Intake Rate(%)
Food Intake Rate(%) for postoperative diet
Time frame: 1 week after discharging (first outpatient follow up)
Diet Intake Rate(%)
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 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care + Nutritional product and Routine care in people with Pancreaticobiliary Cancer, 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 3 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: finished, as of the sponsor's last update on 15 Jan 2019. 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?
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?
Food Intake Rate(%) for postoperative diet (time frame: Pre-operation). The study lists 3 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 15 Jan 2019.