Early-feedingNCT05892263
Jejunostomy-Based Early Enteral Feeding After Esophagectomy
A study testing early feeding in people with Early-feeding, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Early-feeding
- What is being tested?
- early feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2022to 8 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Esophagectomy
- Esophagectomy ＆ reconstruction
- Esophagotomy
- Esophageal reconstruction-with gastric tube
- Esophageal reconstruction-with colon
- Esophageal reconstruction with small intestine
Who cannot join
- Gastrointestinal perforation
- Postoperative hemorrhage
- Intestinal obstruction
- Shock
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Early-feeding
- Being tested
- early feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early feedingOther
Enteral force feeding with 5% dextrose injection within 24 hours after operation
| Study group | Role | What they receive |
|---|---|---|
| Early intestinal force-feeding and drugs to promote gastrointestinal motility | Experimental | Not described Receives: Other: early feeding |
| giving force-feeding after gas or defecation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal emptying time
Start timing the first bowel movement or exhaust time after surgery
Measured: up to 72 hours (time of the first bowel movement or exhaust after surgery )
Secondary outcomes (4)
Infection and Inflammation
Laboratory parameters included white blood cell count, C-reactive protein (CRP), and procalcitonin measured on postoperative day 0 and postoperative day 3
Measured: up to 72 hours
Postoperative complications
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.
Measured: up to72 hours (time of the first bowel movement or exhaust after surgery )
Nutritional risk
Nutritional risk was assessed on postoperative day 3 using the Malnutrition Universal Screening Tool (MUST)
Measured: up to 72 hours
Postoperative recovery
Postoperative recovery measures included length of stay in the intensive care unit, and total hospital length of stay.
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Nov 2022
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-feedingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892263
- Sponsor's protocol ID
- 202205077MIND
- Status last verified
- Jul 2025
- First submitted
- 6 Sep 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05892263
- Acronym / sponsor ID
- 202205077MIND
- Conditions
- Early-feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intestinal force-feeding and drugs to promote gastrointestinal motility | Experimental | Other: early feeding |
| giving force-feeding after gas or defecation | No intervention | – |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Esophagectomy
- Esophagectomy ＆ reconstruction
- Esophagotomy
- Esophageal reconstruction-with gastric tube
- Esophageal reconstruction-with colon
Key exclusion criteria (4 listed)
- Gastrointestinal perforation
- Postoperative hemorrhage
- Intestinal obstruction
- Shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early feedingEnteral force feeding with 5% dextrose injection within 24 hours after operation | Other | Early intestinal force-feeding and drugs to promote gastrointestinal motility |
Primary outcome
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
4 secondary outcomes
Infection and Inflammation
Time frame: up to 72 hours
Postoperative complications
Time frame: up to72 hours (time of the first bowel movement or exhaust after surgery )
Nutritional risk
Time frame: up to 72 hours
Postoperative recovery
Time frame: up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early feeding in people with Early-feeding, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal emptying time (time frame: up to 72 hours (time of the first bowel movement or exhaust after surgery )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.