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

Surgery Clinical Trial

— JNS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318404
• Other study ID #: 2020-1756
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: November 8, 2022

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Jejunostomy feeding
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of body weight loss	Percentage of body weight loss from preoperative body weight	at postoperative 1st visit (postoperative 4-5 weeks)
Secondary	Postoperative complication rate	Postoperative complication rate	From date of randomization until the date of discharge after operation, assessed up to 2 months
Secondary	Complication related to jejunostomy feeding	Complication related to jejunostomy feeding	From date of randomization until the date of discharge after operation, assessed up to 2 months
Secondary	Postoperative Nutritional index	GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin	at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Secondary	Postoperative daily total calorie intake	Postoperative daily total calorie intake (kcal/day)	at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Secondary	Postoperative daily protein intake	Postoperative daily protein intake (g/day)	at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months