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OpenTrials
Completed

NCT Number: NCT05892263

Jejunostomy-Based Early Enteral Feeding After Esophagectomy

Esophagectomy with reconstruction for esophageal cancer is associated with delayed gastrointestinal recovery and substantial postoperative morbidity. Whether early jejunostomy-based enteral feeding can be safely initiated after esophagectomy remains uncertain.

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Key information

Conditions

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early feeding

Other

Enteral force feeding with 5% dextrose injection within 24 hours after operation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. Nutritional risk

    Time frame: up to 72 hours

    Nutritional risk was assessed on postoperative day 3 using the Malnutrition Universal Screening Tool (MUST)

  4. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Jun 17, 2026

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.