Esophageal CancerPhase 3NCT01998230
Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer
A Phase 3 study testing early oral feeding in people with Esophageal Cancer, run by Yin Li at 1 site in China.
Trial summary
The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- early oral feeding
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Oct 2015
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults subject to thoracolaparoscopic esophagectomy for esophageal cancer.
Who cannot join
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b). Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with unstable situation after surgery (eg, need ventilation and ICU treatment) Patients medically unfit for surgical resection. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- Mentally disabled. Expected life duration of less than 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, 450003
About this study
Official title: Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer: a Randomized Clinical Trial
The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in patients with esophagectomy, the preference for this modality also rests on the traditional but undocumented reluctance to allow food at will. These assumed hazards of allowing normal food in the immediate postoperative period have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality. Whether early oral feeding after esophagectomy affects the incidence of life-threatening surgical complications, shortens the recovery time of bowel function and the postoperative hospital stay, improves postoperative quality of life in comparison with artificial feeding modality remains unclear. The investigators compared a routine of allowing liquid food at will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the first 7 postoperative days. The main endpoint is the incidence rate of complications.
Read the detailed description
The literature concludes that patients should be allowed food without delay (at will) after colorectal surgery and that the customary withholding of oral intake (nil-by-mouth) for the first postoperative days is unnecessary. Robust data also suggest that the investigators should avoid the nil-by-mouth regimen after major gynecologic, urologic, and vascular surgery. The safety of early oral feeding after esophagectomy has not been investigated previously.In 2008, the results of a randomized multicenter clinical trial investigating whether a routine of allowing normal food at will immediately increases morbidity after major upper gastrointestinal surgery showed that allowing patients to eat normal food at will from the first day after major upper gastrointestinal surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding. The assumed hazards of allowing oral food intake in the immediate postoperative period in patients with esophagectomy have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality.
This is a randomized study investigating the role of early oral feeding in patients with esophagectomy.In the early oral feeding group nasogastric tube is not placed routinely and patients are encouraged to intake liquid food on postoperative day 1 (POD1). In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of POD 1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h. Esophagography is performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomotic leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. The complications defined in previous study and bowel function and recovery were recorded carefully. The primary end point of this study is the postoperative complications and the secondary end points are quality of life,bowel function recovery time and length of postoperative stay between the two groups. The investigators estimated the minimum rate of patients with complications in control group population at 23%. An increase of this to 36% was considered clinically important. Detecting a difference of this magnitude or greater at a level of statistical significance of 0.05 and a power of 0.90 with a one-tailed test of proportions required a total of 130 patients in each group.Considering the rate of drop-out a total of 280 patients will be enrolled in this study.
- Conditions
- Esophageal Cancer
- Being tested
- early oral feeding
- Keywords
- esophageal cancer, esophagectomy, oral feeding
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early oral feedingDietary supplement
In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.
| Study group | Role | What they receive |
|---|---|---|
| Early oral feeding group | Experimental | In this goup patients with esophagectomy are encouraged to begin the oral intake carefully and adjust according to tolerance on post operative day 1. Receives: Dietary Supplement: early oral feeding |
| Delayed oral feeding group | No intervention | In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of post operative day1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h.Esophagography was performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomosis leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
postoperative complications are graded according to Clavin-Dindo grading system
Measured: an expected average of 4 weeks
Secondary outcomes (2)
Quality of Life assessment
Measured: 6 months
Length of postoperative stay
Measured: an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yin Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yin Li, Henan Cancer Hospital
- Investigators
- Yin Li, Principal investigator, Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998230
- Sponsor's protocol ID
- HenanCH
- Status last verified
- Oct 2015
- First submitted
- 15 Nov 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen X, Wang P, Leng C, Sun H, Liu X, Zhang R, Qin J, Hua X, Yu Y, Li H, Zhang J, Wu Z, Li Y. Early oral feeding after esophagectomy accelerated gut function recovery by regulating brain-gut peptide secretion. Surgery. 2022 Sep;172(3):919-925. doi: 10.1016/j.surg.2022.04.041. Epub 2022 Jul 3.
PubMed 35794044Yang F, Li L, Mi Y, Zou L, Chu X, Sun A, Sun H, Liu X, Xu X. Effectiveness of the Tailored, Early Comprehensive Rehabilitation Program (t-ECRP) based on ERAS in improving the physical function recovery for patients following minimally invasive esophagectomy: a prospective randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):5027-5036. doi: 10.1007/s00520-022-06924-8. Epub 2022 Feb 22.
PubMed 35190895Sun HB, Li Y, Liu XB, Wang ZF, Zhang RX, Lerut T, Zheng Y, Liu SL, Chen XK. Impact of an Early Oral Feeding Protocol on Inflammatory Cytokine Changes After Esophagectomy. Ann Thorac Surg. 2019 Mar;107(3):912-920. doi: 10.1016/j.athoracsur.2018.09.048. Epub 2018 Nov 4.
PubMed 30403976
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01998230
- Acronym / sponsor ID
- HenanCH
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, esophagectomy, oral feeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Yin LiOther government
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in patients with esophagectomy, the preference for this modality also rests on the traditional but undocumented reluctance to allow food at will. These assumed hazards of allowing normal food in the immediate postoperative period have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality. Whether early oral feeding after esophagectomy affects the incidence of life-threatening surgical complications, shortens the recovery time of bowel function and the postoperative hospital stay, improves postoperative quality of life in comparison with artificial feeding modality remains unclear. The investigators compared a routine of allowing liquid food at will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the first 7 postoperative days. The main endpoint is the incidence rate of complications.
Detailed description
The literature concludes that patients should be allowed food without delay (at will) after colorectal surgery and that the customary withholding of oral intake (nil-by-mouth) for the first postoperative days is unnecessary. Robust data also suggest that the investigators should avoid the nil-by-mouth regimen after major gynecologic, urologic, and vascular surgery. The safety of early oral feeding after esophagectomy has not been investigated previously.In 2008, the results of a randomized multicenter clinical trial investigating whether a routine of allowing normal food at will immediately increases morbidity after major upper gastrointestinal surgery showed that allowing patients to eat normal food at will from the first day after major upper gastrointestinal surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding. The assumed hazards of allowing oral food intake in the immediate postoperative period in patients with esophagectomy have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality.
This is a randomized study investigating the role of early oral feeding in patients with esophagectomy.In the early oral feeding group nasogastric tube is not placed routinely and patients are encouraged to intake liquid food on postoperative day 1 (POD1). In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of POD 1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h. Esophagography is performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomotic leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. The complications defined in previous study and bowel function and recovery were recorded carefully. The primary end point of this study is the postoperative complications and the secondary end points are quality of life,bowel function recovery time and length of postoperative stay between the two groups. The investigators estimated the minimum rate of patients with complications in control group population at 23%. An increase of this to 36% was considered clinically important. Detecting a difference of this magnitude or greater at a level of statistical significance of 0.05 and a power of 0.90 with a one-tailed test of proportions required a total of 130 patients in each group.Considering the rate of drop-out a total of 280 patients will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding group | Experimental | Dietary Supplement: early oral feedingIn this goup patients with esophagectomy are encouraged to begin the oral intake carefully and adjust according to tolerance on post operative day 1. |
| Delayed oral feeding group | No intervention | –In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of post operative day1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h.Esophagography was performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomosis leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults subject to thoracolaparoscopic esophagectomy for esophageal cancer.
Key exclusion criteria (3 listed)
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b). Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with unstable situation after surgery (eg, need ventilation and ICU treatment) Patients medically unfit for surgical resection. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- Mentally disabled. Expected life duration of less than 3 months.
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 oral feedingIn the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1. | Dietary supplement | Early oral feeding group |
Primary outcome
Postoperative complication
Time frame: an expected average of 4 weeks
postoperative complications are graded according to Clavin-Dindo grading system
2 secondary outcomes
Quality of Life assessment
Time frame: 6 months
Length of postoperative stay
Time frame: an expected average of 2 weeks
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 16 Oct 2015.
- Derived from this study: PubMed 35794044Chen X, Wang P, Leng C, Sun H, Liu X, Zhang R, Qin J, Hua X, Yu Y, Li H, Zhang J, Wu Z, Li Y. Early oral feeding after esophagectomy accelerated gut function recovery by regulating brain-gut peptide secretion. Surgery. 2022 Sep;172(3):919-925. doi: 10.1016/j.surg.2022.04.041. Epub 2022 Jul 3.
- Derived from this study: PubMed 35190895Yang F, Li L, Mi Y, Zou L, Chu X, Sun A, Sun H, Liu X, Xu X. Effectiveness of the Tailored, Early Comprehensive Rehabilitation Program (t-ECRP) based on ERAS in improving the physical function recovery for patients following minimally invasive esophagectomy: a prospective randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):5027-5036. doi: 10.1007/s00520-022-06924-8. Epub 2022 Feb 22.
- Derived from this study: PubMed 30403976Sun HB, Li Y, Liu XB, Wang ZF, Zhang RX, Lerut T, Zheng Y, Liu SL, Chen XK. Impact of an Early Oral Feeding Protocol on Inflammatory Cytokine Changes After Esophagectomy. Ann Thorac Surg. 2019 Mar;107(3):912-920. doi: 10.1016/j.athoracsur.2018.09.048. Epub 2018 Nov 4.
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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.
Yin Li principal investigator
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing early oral feeding in people with Esophageal Cancer, run by Yin Li at 1 site in China.
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 1 inclusion and 3 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 16 Oct 2015. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative complication (time frame: an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998230, which also lists 3 linked publications.
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 16 Oct 2015.