Condition category
Surgery
Date applied
02/02/2020
Date assigned
19/02/2020
Last edited
03/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://en.z2hospital.com/

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

Publication citations

Additional files

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.