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Trials / Completed

CompletedNCT05318404

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
19 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTJejunostomy feedingMaintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group

Timeline

Start date
2020-12-08
Primary completion
2022-11-08
Completion
2022-11-08
First posted
2022-04-08
Last updated
2022-11-09

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05318404. Inclusion in this directory is not an endorsement.