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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05318404
Collaborator
(none)
58
1
2
24.7
2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Jejunostomy feeding
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 8, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of body weight loss [at postoperative 1st visit (postoperative 4-5 weeks)]

    Percentage of body weight loss from preoperative body weight

Secondary Outcome Measures

  1. Postoperative complication rate [From date of randomization until the date of discharge after operation, assessed up to 2 months]

    Postoperative complication rate

  2. Complication related to jejunostomy feeding [From date of randomization until the date of discharge after operation, assessed up to 2 months]

    Complication related to jejunostomy feeding

  3. Postoperative Nutritional index [at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months]

    GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin

  4. Postoperative daily total calorie intake [at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months]

    Postoperative daily total calorie intake (kcal/day)

  5. Postoperative daily protein intake [at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months]

    Postoperative daily protein intake (g/day)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05318404
Other Study ID Numbers:
  • 2020-1756
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022