Plain English Summary
Background and study aims
Esophageal cancer is a type of cancer affecting the food pipe (esophagus), the long tube that carries food from the throat to the stomach.
In the Ivor Lewis esphagectomy, the esophageal tumor is removed through an abdominal incision and a right thoracotomy (a surgical incision of the chest wall).
The question about how to deal with postoperative feeding after esophageal resection has become an important topic of debate. It has been demonstrated that early oral feeding of patients after thoracolaparoscopic McKeown esophagectomy was feasible and safe. There is no study to test whether early oral feeding policy can be applied after minimally invasive Ivor Lewis intervention with intrathoracic anastomosis.
The aim of this study is to test whether EOF policy (when to eat depending on patients’ willingness) can be applied after minimally invasive Ivor Lewis intervention with intrathoracic anastomosis.
Who can participate?
Patients aged ≥ 18 years and ≤80 years and undergoing minimally invasive Ivor Lewis intervention with intrathoracic anastomosis for esophageal cancer.
What does the study involve?
Participants will be randomly allocated to either resume feeding seven days after surgery (treatment as usual) or to resume feeding once they request food.
What are the possible benefits and risks of participating?
Shorten the length of hospital stay and improve the quality of postoperative life for patients with esophageal cancer are the benefits. Since this clinical study only changed the postoperative feeding time for patients and the incidence of anastomotic fistula after esophageal cancer has been proved to be independent of feeding time. Therefore, this clinical study does not add additional risk to patients.
Where is the study run from?
The Second Affiliated Hospital, Zhejiang University School of Medicine (China)
When is the study starting and how long is it expected to run for?
March 2020 to January 2022
Who is funding the study?
Second Affiliated Hospital of Zhejiang University (China)
Who is the main contact?
Prof. Ming Wu
iwuming22@zju.edu.cn
Trial website
Contact information
Type
Public
Primary contact
Prof Ming Wu
ORCID ID
http://orcid.org/0000-0002-1009-5387
Contact details
Second Affiliated Hospital of Zhejiang University
No. 88 Jiefang road
Hangzhou
31009
China
+86 13757118715
iwuming22@zju.edu.cn
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019-383
Study information
Scientific title
A randomized clinical trial to assess early feeding versus routine feeding for patients who undergo Ivor Lewis minimally invasive esophagectomy
Acronym
Study hypothesis
The aim of this study is to test whether EOF policy (when to eat depending on patients’ willingness) can be applied after minimally invasive Ivor Lewis intervention with intrathoracic anastomosis.
Ethics approval
Approved 06/11/2019, Ethics Committee of the Second Affiliated Hospital of Zhejiang University (No. 88 Jiefang road, Hangzhou city, Zhejiang province, China, 310009; +86 0571-87783759; HREC2013@126.com; ), ref: 2019-383
Study design
Single-center randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Postoperative feeding after esophageal resection
Intervention
Patients were randomly allocated by a computer-generated random number list to receive EOF policy (when to eat depending on patients’ willingness) or LOF (feeding on 7 days after surgery). All the patients underwent minimally invasive Ivor Lewis esophagectomy with 2-field lymph node dissection. Both the groups were treated similarly in the perioperative period.
1. In the EOF group, when the patient complained that he needed to take water or food, then he will be given oral meilan solution. After exclude no anastomotic fistula, the patient will be given postoperative diet
2. In the LOF group, on POD7 esophagography will be performed to exclude anastomotic fistula, and postoperative diet was gradually opened
On the first day of feeding, patients received only water, each time 20-50 ml; if there is no discomfort, on the second day slag-free liquid diet will be received, each time 20-50 ml; if there is no discomfort, on the three day after feeding, transition to a semi-flow diet, mainly porridge, 200 ml each time.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Number of hospital stays after operation. The discharge criteria are: ability to tolerate a soft diet, no signs of a postoperative complication that needed to be treated at the hospital, ability to ambulate without assistance, tolerable pain on oral analgesia and assessed by the attending doctor
Secondary outcome measures
1. Quality of life, measured using the European Organization for Research and Treatment of Cancer (EORCT) assessed within 3 days prior to surgery, 2 weeks , 4 weeks and 3 months after operation
2. General quality of life questionnaire (C30) and OES18 assessed within 3 days prior to surgery, 2 weeks , 4 weeks and 3 months after operation
3. Time in the ICU, morbidity (graded based on the Clavien–Dindo classification)
4. Mortality within 30 days
Overall trial start date
01/02/2020
Overall trial end date
31/01/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Undergoing minimally invasive Ivor Lewis intervention with intrathoracic anastomosis for esophageal cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 patients in each group
Participant exclusion criteria
1. Age ≥ 80 years
2. Exploratory surgery
3. Bilateral recurrent laryngeal nerve (RLN) injury
4. Patients with other malignancies
Recruitment start date
01/03/2020
Recruitment end date
31/12/2021
Locations
Countries of recruitment
China
Trial participating centre
Second Affiliated Hospital of Zhejiang University
No. 88 Jiefang road
Hangzhou
31009
China
Sponsor information
Organisation
Second Affiliated Hospital of Zhejiang University
Sponsor details
No. 88 Jiefang road
Hangzhou
31009
China
+86 13757118715
iwuming22@zju.edu.cn
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Zhejiang University
Alternative name(s)
ZJU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
China
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
31/01/2023
Participant level data
Available on request
Basic results (scientific)
Publication list