Esophageal CancerJNSNCT05318404
Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)
A study testing Jejunostomy feeding in people with Esophageal Cancer and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Esophageal Cancer, Surgery, Jejunostomy; Complications
- What is being tested?
- Jejunostomy feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2020to 8 Nov 2022
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose
- Patients who can understand the purpose and protocol of the clinical trial
Who cannot join
- BMI < 18kg/m2 or BMI > 25kg/m2
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer
Read the detailed description
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.
- Being tested
- Jejunostomy feeding
- Keywords
- esophagectomy, esophageal cancer, nutritional support, jejunostomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunostomy feedingDietary supplement
Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
| Study group | Role | What they receive |
|---|---|---|
| Conventinal feeding group | No intervention | Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source |
| Delayed feeding group | Experimental | 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 Receives: Dietary Supplement: Jejunostomy feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of body weight loss
Percentage of body weight loss from preoperative body weight
Measured: at postoperative 1st visit (postoperative 4-5 weeks)
Secondary outcomes (5)
Postoperative complication rate
Postoperative complication rate
Measured: From date of randomization until the date of discharge after operation, assessed up to 2 months
Complication related to jejunostomy feeding
Complication related to jejunostomy feeding
Measured: From date of randomization until the date of discharge after operation, assessed up to 2 months
Postoperative Nutritional index
GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin
Measured: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily total calorie intake
Postoperative daily total calorie intake (kcal/day)
Measured: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily protein intake
Postoperative daily protein intake (g/day)
Measured: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start8 Dec 2020
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318404
- Sponsor's protocol ID
- 2020-1756
- Acronym
- JNS
- Status last verified
- Nov 2022
- First submitted
- 22 Mar 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05318404
- Acronym / sponsor ID
- JNS / 2020-1756
- Keywords
- esophagectomy, esophageal cancer, nutritional support, jejunostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 8 Apr 2022 (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.
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventinal feeding group | No intervention | –Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source |
| Delayed feeding group | Experimental | Dietary Supplement: Jejunostomy feedingStart 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 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose
- Patients who can understand the purpose and protocol of the clinical trial
Key exclusion criteria (6 listed)
- BMI < 18kg/m2 or BMI > 25kg/m2
- 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)
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 |
|---|---|---|
| Jejunostomy feedingMaintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group | Dietary supplement | Delayed feeding group |
Primary outcome
Percentage of body weight loss
Time frame: at postoperative 1st visit (postoperative 4-5 weeks)
Percentage of body weight loss from preoperative body weight
5 secondary outcomes
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: From date of randomization until the date of discharge after operation, assessed up to 2 months
Postoperative Nutritional index
Time frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily total calorie intake
Time frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
Postoperative daily protein intake
Time frame: at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months
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 9 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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 Jejunostomy feeding in people with Esophageal Cancer and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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 9 Nov 2022. 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 South Korea. 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?
Percentage of body weight loss (time frame: at postoperative 1st visit (postoperative 4-5 weeks)). 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 9 Nov 2022.