Clinical Validation of Nutritional Supplements Developed... | NCT03294096

Studies
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

NCT03294096

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 15, 2019Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Pancreaticobiliary Cancer

Interventions

Routine care + Nutritional product
Routine care

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2017Actual

Primary Completion Date

Jul 11, 2018Actual

Completion Date

Jul 11, 2018Actual

First Submitted Date

Sep 18, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2019

Last Update Posted Date

Jan 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental		Dietary Supplement: Routine care + Nutritional product
control group	Active Comparator		Other: Routine care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine care + Nutritional product	Dietary Supplement	Routine post-op care + Nutritional supplement by specific product	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	Pre-operation
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	1 day before discharging
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	1 week after discharging (first outpatient follow up)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine		Seoul		03722	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided