- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892263
Jejunostomy-Based Early Enteral Feeding After Esophagectomy
The Study Wonders Whether Early Gastric Force Feeding Can Reduce the Infection Rate and Whether the External Reaction Can Simultaneously Promote the Gastric Motility of the Gastrointestinal Tract Peristalsis Can Reduce the Complications of Postoperative Neck and Wound Anastomosis Leakage, Provide Postoperative Care for Intact Esophagus, and Reduce Postoperative Mortality.
Study Overview
Detailed Description
Esophageal cancer remains a major gastrointestinal malignancy worldwide. For patients with resectable disease, esophagectomy with reconstruction remains the main curative treatment. Although the overall 5-year survival rate of esophageal cancer has historically been poor, often around 10% to 15%, contemporary surgical series have reported 5-year survival rates approaching 40% or higher in selected patients undergoing resection. Even so, esophagectomy remains a high-risk procedure. Despite advances in minimally invasive techniques and perioperative care pathways, postoperative complications such as pulmonary infection, delayed gastrointestinal recovery, and anastomosis-related complications remain common. Postoperative ileus and systemic inflammatory response can prolong intensive care unit (ICU) and hospital stay, increase health care resource utilization, and add substantially to patient burden. Accordingly, optimizing postoperative recovery has become a major priority in contemporary esophageal surgery.
The intestine is increasingly recognized as a key organ in immune and metabolic regulation. Delayed enteral nutrition may lead to intestinal mucosal atrophy, impaired gut barrier function, and bacterial translocation, thereby exacerbating systemic inflammatory responses. Current critical care and clinical nutrition guidelines generally recommend initiation of enteral nutrition within 24 to 48 hours in hemodynamically stable patients to preserve intestinal integrity and reduce the risk of infection. Enhanced recovery after surgery (ERAS) protocols likewise advocate early enteral nutrition as part of strategies to accelerate postoperative recovery. Although previous studies
have suggested that early enteral nutrition may improve gastrointestinal recovery and reduce infectious complications, its clinical value after esophagectomy with reconstruction has not yet been clearly established. Concerns remain regarding possible adverse effects of early feeding on anastomotic healing, gastric emptying, and postoperative respiratory function, and published findings have varied across clinical settings. In particular, the optimal route of nutritional support, whether oral feeding, nasogastric tube feeding, or jejunostomy feeding, remains uncertain, especially with respect to anastomotic integrity, pulmonary complications, and other perioperative outcomes. These uncertainties continue to support further investigation of early enteral nutrition in patients undergoing esophageal cancer surgery.
Against this background, we conducted a randomized controlled trial in patients undergoing esophagectomy with reconstruction for esophageal cancer to compare 2 postoperative enteral nutrition strategies delivered via jejunostomy: initiation within 24 hours after surgery and initiation after the first postoperative bowel movement under conventional care. The primary objective was to determine whether earlier enteral feeding improved gastrointestinal functional recovery after esophagectomy. We also performed exploratory analyses of perioperative laboratory parameters, postoperative complications, and other indicators of early postoperative recovery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Esophagectomy
- Esophagectomy & reconstruction
- Esophagotomy
- Esophageal reconstruction-with gastric tube
- Esophageal reconstruction-with colon
- Esophageal reconstruction with small intestine
Exclusion Criteria:
- Gastrointestinal perforation
- Postoperative hemorrhage
- Intestinal obstruction
- Shock
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early intestinal force-feeding and drugs to promote gastrointestinal motility
|
Enteral force feeding with 5% dextrose injection within 24 hours after operation
|
|
No Intervention: giving force-feeding after gas or defecation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gastrointestinal emptying time
Time Frame: up to 72 hours (time of the first bowel movement or exhaust after surgery )
|
Start timing the first bowel movement or exhaust time after surgery
|
up to 72 hours (time of the first bowel movement or exhaust after surgery )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infection and Inflammation
Time Frame: up to 72 hours
|
Laboratory parameters included white blood cell count, C-reactive protein (CRP), and procalcitonin measured on postoperative day 0 and postoperative day 3
|
up to 72 hours
|
|
Postoperative complications
Time Frame: up to72 hours (time of the first bowel movement or exhaust after surgery )
|
Postoperative complications included pneumonia, anastomotic leakage, vocal cord palsy, bloodstream infection, arrhythmia requiring medication control, pleural effusion, pneumothorax, acute lung injury, chylous leakage, postoperative delirium, systemic inflammatory response syndrome (SIRS), and SIRS score.
|
up to72 hours (time of the first bowel movement or exhaust after surgery )
|
|
Nutritional risk
Time Frame: up to 72 hours
|
Nutritional risk was assessed on postoperative day 3 using the Malnutrition Universal Screening Tool (MUST)
|
up to 72 hours
|
|
Postoperative recovery
Time Frame: up to 60 days
|
Postoperative recovery measures included length of stay in the intensive care unit, and total hospital length of stay.
|
up to 60 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202205077MIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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