NCT02964806

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 for pancreaticobiliary cancer patients. The investigators expect that customized diets 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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

November 7, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

November 13, 2016

Last Update Submit

March 13, 2018

Conditions

Ketogen-based Therapeutic DietPancreaticobiliary Cancer

Outcome Measures

Primary Outcomes (1)

  • Food Intake Rate(%) for postoperative diet

    Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.

    3 days after the diet

Study Arms (3)

Ordinary Diet

OTHER

Ordinary Diet

Dietary Supplement: Ordinary Diet

Modified Atkin's Diet

OTHER

Modified Atkin's Diet

Dietary Supplement: Modified Atkin's Diet

Ketogenic Diet

OTHER

Ketogenic Diet

Dietary Supplement: Ketogenic Diet

Interventions

Ordinary DietDIETARY_SUPPLEMENT
Ordinary Diet
Modified Atkin's DietDIETARY_SUPPLEMENT
Modified Atkin's Diet
Ketogenic DietDIETARY_SUPPLEMENT
Ketogenic Diet

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\<90%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

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

November 13, 2016

First Posted

November 16, 2016

Study Start

November 7, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)