Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT05318404
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer
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Notify Me19 year–75 year
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
Time frame: at postoperative 1st visit (postoperative 4-5 weeks)
Percentage of body weight loss from preoperative body weight
Time frame: From date of randomization until the date of discharge after operation, assessed up to 2 months
Postoperative complication rate
Time frame: From date of randomization until the date of discharge after operation, assessed up to 2 months
Complication related to jejunostomy feeding
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
Time frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily total calorie intake (kcal/day)
Time frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily protein intake (g/day)
Seoul National University Hospital
Other
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
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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