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Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study) (JNS)

Primary Purpose

Esophageal Cancer, Surgery, Jejunostomy; Complications

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Jejunostomy feeding
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophagectomy, esophageal cancer, nutritional support, jejunostomy

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose
  • Patients who can understand the purpose and protocol of the clinical trial

Exclusion Criteria:

  • BMI < 18kg/m2 or BMI > 25kg/m2
  • Patients who needs colon of jejunum for esophageal reconstruction
  • Patients who needed enteral feeding before esophagectomy
  • Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure)
  • Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease)
  • Other patients who are not suitable for clinical trial

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventinal feeding group

Delayed feeding group

Arm Description

Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source

Start clear liquid fluid diet 5-7 days after esophagectomy and discharge with jejunostomy feeding as the major energy source. Start oral feeding at postoperative 1st visit

Outcomes

Primary Outcome Measures

Percentage of body weight loss
Percentage of body weight loss from preoperative body weight

Secondary Outcome Measures

Postoperative complication rate
Postoperative complication rate
Complication related to jejunostomy feeding
Complication related to jejunostomy feeding
Postoperative Nutritional index
GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin
Postoperative daily total calorie intake
Postoperative daily total calorie intake (kcal/day)
Postoperative daily protein intake
Postoperative daily protein intake (g/day)

Full Information

First Posted
March 22, 2022
Last Updated
November 8, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05318404
Brief Title
Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)
Acronym
JNS
Official Title
Comparison of Clinical Outcomes and Nutritional Status Between Conventional Oral Intake and Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy: An Open Labeled Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer
Detailed Description
Esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and is associated with a poor prognosis. The 5-year overall survival rate is 40.0 % and the 30-day mortality rate is 1.7 %. Surgical resection is the most effective treatment for localized esophageal cancer; however, esophagectomy is extremely invasive and is associated with high morbidity and mortality rates. Nutrition is one of the most important factors to consider after esophagectomy in order to reduce surgical mortality. The European Society for Parenteral and Enteral Nutrition guidelines recommend early tube feeding after major gastrointestinal surgery for cancer. Several studies have shown that enteral nutrition is more effective than parenteral nutrition in reducing postoperative complications in postesophagectomy patients. It has been reported that 5 to 7 days are required for anastomosis site healing. Therefore, many centers start oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation, and enteral feeding via jejunostomy are maintained for nutritional support. However, the optimal timing for oral feeding after esophagectomy is still under debate. In our center, the investigators routinely place jejunostomy tube for sufficient enteral feeding after esophagectomy. Before 2014, the investigators started oral feeding 5 to 7 days after esophagectomy and patients were discharged with soft blended diet. After 2014, the investigators changed our postoperative management protocols: 1) the investigators started only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube. However, no studies have been conducted showing the optimal timing for oral feeding for esophagectomy patients for nutritional support and postoperative care. The investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy feeding is superior to conventional oral feeding for nutritional support and early clinical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Surgery, Jejunostomy; Complications, Nutrition Related Cancer
Keywords
esophagectomy, esophageal cancer, nutritional support, jejunostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventinal feeding group
Arm Type
No Intervention
Arm Description
Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source
Arm Title
Delayed feeding group
Arm Type
Experimental
Arm Description
Start clear liquid fluid diet 5-7 days after esophagectomy and discharge with jejunostomy feeding as the major energy source. Start oral feeding at postoperative 1st visit
Intervention Type
Dietary Supplement
Intervention Name(s)
Jejunostomy feeding
Intervention Description
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
Primary Outcome Measure Information:
Title
Percentage of body weight loss
Description
Percentage of body weight loss from preoperative body weight
Time Frame
at postoperative 1st visit (postoperative 4-5 weeks)
Secondary Outcome Measure Information:
Title
Postoperative complication rate
Description
Postoperative complication rate
Time Frame
From date of randomization until the date of discharge after operation, assessed up to 2 months
Title
Complication related to jejunostomy feeding
Description
Complication related to jejunostomy feeding
Time Frame
From date of randomization until the date of discharge after operation, assessed up to 2 months
Title
Postoperative Nutritional index
Description
GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin
Time Frame
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Title
Postoperative daily total calorie intake
Description
Postoperative daily total calorie intake (kcal/day)
Time Frame
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Title
Postoperative daily protein intake
Description
Postoperative daily protein intake (g/day)
Time Frame
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose Patients who can understand the purpose and protocol of the clinical trial Exclusion Criteria: BMI < 18kg/m2 or BMI > 25kg/m2 Patients who needs colon of jejunum for esophageal reconstruction Patients who needed enteral feeding before esophagectomy Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure) Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease) Other patients who are not suitable for clinical trial
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)

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