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

November 8, 2022 updated by: Seoul National University Hospital

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

Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventinal feeding group
Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source
Experimental: Delayed feeding group
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
Dietary supplement: Jejunostomy feeding
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of body weight loss
Time Frame: at postoperative 1st visit (postoperative 4-5 weeks)
Percentage of body weight loss from preoperative body weight
at postoperative 1st visit (postoperative 4-5 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication rate
Time Frame: From date of randomization until the date of discharge after operation, assessed up to 2 months
Postoperative complication rate
From date of randomization until the date of discharge after operation, assessed up to 2 months
Complication related to jejunostomy feeding
Time Frame: From date of randomization until the date of discharge after operation, assessed up to 2 months
Complication related to jejunostomy feeding
From date of randomization until the date of discharge after operation, assessed up to 2 months
Postoperative Nutritional index
Time Frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily total calorie intake
Time Frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily total calorie intake (kcal/day)
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily protein intake
Time Frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily protein intake (g/day)
at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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