Nutritional SupportNCT06397430
Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone
A study testing parenteral nutrition supplements, enteral nutrition supplements and mixed nutrition supplements in people with Nutritional Support and Hepato-Biliary Neoplasm, run by Karaganda Medical University at 1 site in Kazakhstan.
Trial summary
A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Nutritional Support, Hepato-Biliary Neoplasm, Postoperative
- What is being tested?
- parenteral nutrition supplements, enteral nutrition supplements and mixed nutrition supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Dec 2017to 28 Feb 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:
- resection of various segments of the liver;
- hemihepatectomy;
- transhepatic drainage of the right and left hepatic duct;
- bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
- gastro-pancreatoduodenal resection;
- corporecaudal resection of the pancreas with splenectomy.
Who cannot join
- patients in age of up to 20 and older than 75
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period
A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.
Read the detailed description
A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:
- resection of various segments of the liver;
- hemihepatectomy;
- transhepatic drainage of the right and left hepatic duct;
- bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
- gastro-pancreato-duodenal resection;
- corpore-caudal resection of the pancreas with splenectomy.
The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.
Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status
- Conditions
- Nutritional Support, Hepato-Biliary Neoplasm, Postoperative
- Being tested
- parenteral nutrition supplements, enteral nutrition supplements, mixed nutrition supplements
- Keywords
- nutritional support, Hepato-Biliary Neoplasm, postoperative curation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parenteral nutrition supplementsDietary supplement
Also called parenteral nutrition
parenteral nutrition
enteral nutrition supplementsDietary supplement
Also called enteral nutrition
enteral nutrition
mixed nutrition supplementsDietary supplement
Also called mixed nutrition
mixed nutrition
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - enteral nutrition | Experimental | patients receiving enteral nutrition (EN) after surgery Receives: Dietary Supplement: enteral nutrition supplements |
| Arm 2 - parenteral nutrition | Experimental | patients receiving parenteral nutrition (PN) Receives: Dietary Supplement: parenteral nutrition supplements |
| Arm 3 - mixed nutrition | Experimental | patients receiving mixed nutrition (MF) Receives: Dietary Supplement: mixed nutrition supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with changes of BMI in kg/m^2
Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults
Measured: Day 0, Day 5, Day 10, Day15
Basal Metabolic rate
basal metabolic rate according to the Harris-Benedict equation
Measured: Day 0, Day 5, Day 10, Day15
Total protein level in Blood
Blood biochemical analysis: total protein in g/L
Measured: Day 0, Day 5, Day 10, Day15
Serum albumin in g/L
Blood biochemical analysis: serum albumin in g/L
Measured: Day 0, Day 5, Day 10, Day15
Serum transferrin in g/L
Blood biochemical analysis: serum transferrin in g/L
Measured: Day 0, Day 5, Day 10, Day15
Total bilirubin in mmol/L
Blood biochemical analysis: total bilirubin in mmol/L
Measured: Day 0, Day 5, Day 10, Day15
Direct bilirubin in mmol/L
Blood biochemical analysis: direct bilirubin in mmol/L
Measured: Day 0, Day 5, Day 10, Day15
ALT in IU/L
Blood biochemical analysis: ALT in IU/L
Measured: Day 0, Day 5, Day 10, Day15
AST in IU/L
Blood biochemical analysis: AST in IU/L
Measured: Day 0, Day 5, Day 10, Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Dec 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupportStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, longitudinal, parallel study
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaganda Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherzad Davanov, MD, Principal investigator, Karaganda Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397430
- Sponsor's protocol ID
- MUK_NutS-HPD-PO_2017
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT06397430
- Acronym / sponsor ID
- MUK_NutS-HPD-PO_2017
- Conditions
- Nutritional Support, Hepato-Biliary Neoplasm, Postoperative
- Keywords
- nutritional support, Hepato-Biliary Neoplasm, postoperative curation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Karaganda Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 2 May 2024 (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.
A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.
Detailed description
A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:
- resection of various segments of the liver;
- hemihepatectomy;
- transhepatic drainage of the right and left hepatic duct;
- bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
- gastro-pancreato-duodenal resection;
- corpore-caudal resection of the pancreas with splenectomy.
The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.
Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, longitudinal, parallel study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - enteral nutrition | Experimental | Dietary Supplement: enteral nutrition supplementspatients receiving enteral nutrition (EN) after surgery |
| Arm 2 - parenteral nutrition | Experimental | Dietary Supplement: parenteral nutrition supplementspatients receiving parenteral nutrition (PN) |
| Arm 3 - mixed nutrition | Experimental | Dietary Supplement: mixed nutrition supplementspatients receiving mixed nutrition (MF) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:
- resection of various segments of the liver;
- hemihepatectomy;
- transhepatic drainage of the right and left hepatic duct;
- bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
Key exclusion criteria (2 listed)
- patients in age of up to 20 and older than 75
- pregnant and breastfeeding women
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 |
|---|---|---|
| parenteral nutrition supplementsAlso: parenteral nutritionparenteral nutrition | Dietary supplement | Arm 2 - parenteral nutrition |
| enteral nutrition supplementsAlso: enteral nutritionenteral nutrition | Dietary supplement | Arm 1 - enteral nutrition |
| mixed nutrition supplementsAlso: mixed nutritionmixed nutrition | Dietary supplement | Arm 3 - mixed nutrition |
Primary outcome
Number of Participants with changes of BMI in kg/m^2
Time frame: Day 0, Day 5, Day 10, Day15
Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults
Basal Metabolic rate
Time frame: Day 0, Day 5, Day 10, Day15
basal metabolic rate according to the Harris-Benedict equation
Total protein level in Blood
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: total protein in g/L
Serum albumin in g/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: serum albumin in g/L
Serum transferrin in g/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: serum transferrin in g/L
Total bilirubin in mmol/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: total bilirubin in mmol/L
Direct bilirubin in mmol/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: direct bilirubin in mmol/L
ALT in IU/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: ALT in IU/L
AST in IU/L
Time frame: Day 0, Day 5, Day 10, Day15
Blood biochemical analysis: AST in IU/L
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 2 May 2024.
- 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.
Sherzad Davanov, MD principal investigator
Karaganda Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parenteral nutrition supplements, enteral nutrition supplements and mixed nutrition supplements in people with Nutritional Support and Hepato-Biliary Neoplasm, run by Karaganda Medical University at 1 site in Kazakhstan.
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 7 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: finished, as of the sponsor's last update on 2 May 2024. 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 Kazakhstan. 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?
Number of Participants with changes of BMI in kg/m^2 (time frame: Day 0, Day 5, Day 10, Day15). The study lists 9 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 2 May 2024.