NCT03294096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

September 18, 2017

Last Update Submit

January 14, 2019

Conditions

Pancreaticobiliary Cancer

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

experimental group

EXPERIMENTAL
Dietary Supplement: Routine care + Nutritional product

control group

ACTIVE COMPARATOR
Other: Routine care

Interventions

Routine care + Nutritional productDIETARY_SUPPLEMENT

Routine post-op care + Nutritional supplement by specific product

experimental group
Routine careOTHER

Routine post-op care

control group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 26, 2017

Study Start

September 4, 2017

Primary Completion

July 11, 2018

Study Completion

July 11, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

KR(1)