Early feeding versus routine feeding after tumor removal using Ivor Lewis minimally invasive esophagectomy
| ISRCTN | ISRCTN16281941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16281941 |
| Secondary identifying numbers | 2019-383 |
- Submission date
- 02/02/2020
- Registration date
- 19/02/2020
- Last edited
- 03/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Second Affiliated Hospital of Zhejiang University
No. 88 Jiefang road
Hangzhou
31009
China
 ORCID ID |
0000-0002-1009-5387 |
|---|---|
| Phone | +86 13757118715 |
| iwuming22@zju.edu.cn |
Study information
| Study design | Single-center randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomized clinical trial to assess early feeding versus routine feeding for patients who undergo Ivor Lewis minimally invasive esophagectomy |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2020 |
| Completion date | 31/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 patients in each group |
| Key inclusion criteria | 1. Aged ≥18 years 2. Undergoing minimally invasive Ivor Lewis intervention with intrathoracic anastomosis for esophageal cancer |
| Key exclusion criteria | 1. Age ≥ 80 years 2. Exploratory surgery 3. Bilateral recurrent laryngeal nerve (RLN) injury 4. Patients with other malignancies |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Hangzhou
31009
China
Sponsor information
Hospital/treatment centre
No. 88 Jiefang road
Hangzhou
31009
China
| Phone | +86 13757118715 |
|---|---|
| iwuming22@zju.edu.cn | |
| Website | http://en.z2hospital.com/ |
"ROR" |
https://ror.org/059cjpv64 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- 浙江大学, 浙江大學, Chekiang University, Chekiang Higher Institutes, National Third Chungshan University, National Chekiang University, ZJU, NCKU
- Location
- China
Results and Publications
| Intention to publish date | 31/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Editorial Notes
03/03/2020: Internal review.
11/02/2020: Trial’s existence confirmed by Ethics Committee of the Second Affiliated Hospital of Zhejiang University.
