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

NCT05318404 | Completed DMC

• 1 other identifier: 2020-1756
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer; Surgery; Jejunostomy; Complications; Nutrition Related Cancer

Keywords

esophagectomy; esophageal cancer; nutritional support; jejunostomy

Outcome Measures

Primary Outcomes (1)

• Percentage of body weight loss

  Percentage of body weight loss from preoperative body weight

  at postoperative 1st visit (postoperative 4-5 weeks)

Secondary Outcomes (5)

• Postoperative complication rate

  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

  at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months

• Postoperative daily total calorie intake

  at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months

• Postoperative daily protein intake

  at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months

Study Arms (2)

Conventinal feeding group

NO INTERVENTION

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

Delayed feeding group

EXPERIMENTAL

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

Interventions

Jejunostomy feeding DIETARY_SUPPLEMENT

Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group

Delayed feeding group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: December 8, 2020
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

KR (1)