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Completed

NCT Number: NCT05318404

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

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

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jejunostomy feeding

Dietary Supplement

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

Primary outcomes

  1. Percentage of body weight loss

    Time frame: at postoperative 1st visit (postoperative 4-5 weeks)

    Percentage of body weight loss from preoperative body weight

Secondary outcomes

  1. Postoperative complication rate

    Time frame: 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

    Time frame: 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

    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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: JNS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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