Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)
NCT ID: NCT05318404
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
58 participants
INTERVENTIONAL
2020-12-08
2022-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
NCT01669356
Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
NCT03676478
Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
NCT03545490
Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy
NCT01870817
Goal-directed Enteral Nutritional Perioperative Management
NCT06510543
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventinal feeding group
Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source
No interventions assigned to this group
Delayed feeding group
Start clear liquid fluid diet 5-7 days after esophagectomy and discharge with jejunostomy feeding as the major energy source. Start oral feeding at postoperative 1st visit
Jejunostomy feeding
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Jejunostomy feeding
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who can understand the purpose and protocol of the clinical trial
Exclusion Criteria
* Patients who needs colon of jejunum for esophageal reconstruction
* Patients who needed enteral feeding before esophagectomy
* Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure)
* Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease)
* Other patients who are not suitable for clinical trial
19 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-1756
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.