Clinical trial NCT05318404: Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)
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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Surgery
Jejunostomy; Complications
Nutrition Related Cancer
Keywords: esophagectomy
esophageal cancer
nutritional support
jejunostomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of body weight loss
timeFrame: at postoperative 1st visit (postoperative 4-5 weeks)
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: From date of randomization until the date of discharge after operation, assessed up to 2 months
measure: Complication related to jejunostomy feeding
timeFrame: From date of randomization until the date of discharge after operation, assessed up to 2 months
measure: Postoperative Nutritional index
timeFrame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
measure: Postoperative daily total calorie intake
timeFrame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
measure: Postoperative daily protein intake
timeFrame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: