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Trial registered on ANZCTR


Registration number
ACTRN12616000697482
Ethics application status
Approved
Date submitted
4/04/2016
Date registered
26/05/2016
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Percutaneous endoscopic gastrostomy (PEG) tube feeding in patients with esophageal cancer scheduled for chemoradiotherapy
Scientific title
Effect of percutaneous endoscopic gastrostomy (PEG) tube feeding on nutritional status in patients undergoing chemoradiotherapy for esophageal cancer
Secondary ID [1] 288902 0
None
Universal Trial Number (UTN)
U1111-1181-4771
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal cancer 298237 0
Nutrition 298238 0
Condition category
Condition code
Cancer 298376 298376 0 0
Oesophageal (gullet)
Diet and Nutrition 298801 298801 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Patients with esophagus cancer (squamous cell carcinoma and adenocarcinoma) and esophageal-gastric junction cancer, Siewert I, (adenocarcinoma) with dysphagia (grade>2) and/or weight loss (>10% normal body weight), proposed for isolated or neoadjuvant chemoradiotherapy (CRT) will be proposed for percutaneous endoscopic gastrostomy (PEG) placement on the multidisciplinary meeting, prior to the onset of therapeutic protocol (1-3 weeks before chemoradiotherapy treatment starts based on the clinical discretion of the treating gastoenterologist);
- PEG will be placed by two gastroenterologists, by the pull method, with antibiotic prophylaxis with intravenous cefazoline (2g) administered immediately before procedure and at 8 and 16 hours post procedure. The patient will admitted for 24 hours at the Gastroenterology Department, post PEG placement procedure, and will start stoma enteral infusion after 6 hours and enteral bolus on the following day, if no complications have been registered;
- If the esophageal tumor is stenotic, an esophageal dilation may be necessary. This procedure will be done by a gastroenterologist with more than 5 years' experience, using Savary-Gilliard"Registered Trademark" Dilator or esophageal dilatation balloon; patients with stenotic tumour will be identified prior to PEG placement procedure on basis of previous upper endoscopy report and PEG will be placed on the same day of the esophageal dilation;
- After PEG insertion a peri-stoma cytology will be done by on of the gastroenterologists, with subsequent cytopathological evaluation;
- The patient can keep oral diet in addition to enteral nutrition throughout the course of treatment; nutritional plan will be made by a dietitian and diet consists of food administered by bolus through the PEG with or without nutritional supplements according to the nutritional needs and degree of dysphagia;
- In patients undergoing oesophagectomy, the PEG will be removed during surgery and the peri-stoma tissue will be sent for histopathological evaluation (tumor seeding);
- In patients that do not undergo surgery the PEG will be removed at the end of the treatment after confirm that the patient eats the entire diet by the oral route.
- Histopathological evaluation will be done by a pathologist with expertise in digestive pathology (more than 10 years' experience);
- All surgical and post-surgical complications, the nutritional outcomes and any complications related to PEG will be registered. The weight will be recorded every two weeks before the start of therapy, weekly during the CRT, and after the CRT (end, after 2 weeks, after 4 weeks), and one month after surgery. All the records will be made by a nurse with more than 5 years' experience in the management of patients with gastrostomies, with the assistance of a dietitian with more than 5 years' experience on the management of oncological patients.
Intervention code [1] 294365 0
Treatment: Devices
Comparator / control treatment
The control group will be a historical cohort of patients with the same characteristics (grade of dysphagia, weight loss, treatment with CRT) and also patients who met inclusion criteria but decline PEG placement.
The time period for historical control will be 12 months before the start of this protocol (May 2015 - April 2016) and the source will be the database of esophageal-gastric multidisciplinary team and clinical records of the patients.
Control group
Historical

Outcomes
Primary outcome [1] 297862 0
Assess the impact of PEG placement in the nutritional status of patients with esophageal cancer proposed to chemoradiotherapy (CRT)
--> measured by: BMI fluctuation:
- if esophagectomy: before surgery-diagnosis;
- if definitive CRT: post-therapeutic-diagnosis

BMI= weight in kilograms divided by the square of height in meters
Timepoint [1] 297862 0
- if esophagectomy: before surgery-diagnosis
- if definitive CRT: post-therapeutic-diagnosis
Secondary outcome [1] 322475 0
Composite secondary outcome: to evaluate the safety of PEG placement procedure by review of medical records:

- Complications of PEG (yes /no)
- Type of complications: peri-stomal infection, bleeding, burried bumper syndrome, accidental extrusion PEG
- Approach to complications: medical, endoscopic, surgical
- Grade of severity: minor- medical approach, major- endoscopic or surgical approach
- If infection: a single agent, number of agents, use of antibiotics (yes /no)
Timepoint [1] 322475 0
Immediate complications: <=24 hours
Early complications: >24 hours to <7 days
Delayed complications: >=7 days
Secondary outcome [2] 322559 0
To assess the risk of infeasibility on the use of stomach as gastric tube for anatomic reconstruction after esophagectomy: if the surgeon considers that is not possible to use the gastric tube for esophageal reconstruction and have to use colon interposition - assessed by review of medical records.
Timepoint [2] 322559 0
Time of surgery (only apply to surgical patients)
Secondary outcome [3] 322560 0
To assess the risk of stoma tumor seeding: Tumor seeding (yes / no)
Timepoint [3] 322560 0
At the time of PEG placement: 1 week after placement (after cytological evaluation, by swab)

In the withdrawal of PEG:
- if surgery: 1 week after the surgery (after histological evaluation);
- if definitive CRT: 1 week after PEG removal, after the end of the treatment (after cytological evaluation, by swab)
Secondary outcome [4] 322561 0
Composite outcome: to assess the rate of overall complications by review of medical records:
- surgical / postoperative (yes / no; which), non-elective admission during therapy (yes / no)
Timepoint [4] 322561 0
After PEG placement
After Surgery (1 month)

Eligibility
Key inclusion criteria
Patients with esophagus cancer (squamous cell carcinoma and adenocarcinoma) and esophageal-gastric junction cancer, Siewert I, (adenocarcinoma) with dysphagia (grade> 2) and/or weight loss (> 10% normal body weight), proposed for definitive or neoadjuvant CRT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for PEG placement:
- patients with no ability to take care of PEG,
- decompensated chronic liver disease,
- presence of clinically significant ascites.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed with the SPSS Statistics (IBM).
- Analysis of the outcomes will be compared with a historic cohort and with patients who met inclusion criteria but refuse PEG placement.
- Continuous variables will be expressed as means and standard deviations and compared by the T-student test or Wilcoxon.
- Qualitative variables will be expressed as absolute and/or relative frequencies and correlated by chi-square test or Fisher's Exact test.
- To correlate multiple variables, logistic regression analysis will be done.
- A value of p <0.05 is considered statistically significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2016
Date of last participant enrolment
Anticipated
31/05/2019
Actual
15/01/2020
Date of last data collection
Anticipated
29/01/2021
Actual
Sample size
Target
30
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 7772 0
Portugal
State/province [1] 7772 0
Lisbon

Funding & Sponsors
Funding source category [1] 293284 0
Hospital
Name [1] 293284 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Country [1] 293284 0
Portugal
Primary sponsor type
Hospital
Name
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Address
Rua Prof. Lima Basto, 1099-023, Lisbon
Country
Portugal
Secondary sponsor category [1] 292085 0
None
Name [1] 292085 0
Address [1] 292085 0
Country [1] 292085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294759 0
Ethics committee - Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Ethics committee address [1] 294759 0
Rua Prof. Lima Basto, 1099-023 Lisbon
Ethics committee country [1] 294759 0
Portugal
Date submitted for ethics approval [1] 294759 0
22/10/2015
Approval date [1] 294759 0
04/02/2016
Ethics approval number [1] 294759 0
UIC/1011

Summary
Brief summary
The project proposes to evaluate the benefits and possible complications associated with PEG placement in a group of patients with esophageal cancer proposed for CRT, a group of high nutritional risk. The adoption of a new strategy may, in addition to improve patients quality of life, reduce healthcare costs by reducing the number of non-elective admissions. Informed consent is complete and explicit and the fundamental rights to voluntary participation and to not prejudice health care in case of refusal are included, as well as personal data confidentiality. The ethics committee believes that this study falls within the objectives of the Portuguese Institute of Oncology of Lisbon, so it should be approved.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 824 824 0 0
/AnzctrAttachments/370451-Ethics approval.pdf
Attachments [2] 825 825 0 0
/AnzctrAttachments/370451-Ethics approval2.pdf

Contacts
Principal investigator
Name 64862 0
Dr Joana Lemos Garcia
Address 64862 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Basto 1099-023 Lisbon
Country 64862 0
Portugal
Phone 64862 0
+351918874227
Fax 64862 0
Email 64862 0
[email protected]
Contact person for public queries
Name 64863 0
Joana Lemos Garcia
Address 64863 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Bastos, 1099-023 Lisbon
Country 64863 0
Portugal
Phone 64863 0
+351918874227
Fax 64863 0
Email 64863 0
[email protected]
Contact person for scientific queries
Name 64864 0
Joana Lemos Garcia
Address 64864 0
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Rua Prof. Lima Bastos, 1099-023 Lisbon
Country 64864 0
Portugal
Phone 64864 0
+351918874227
Fax 64864 0
Email 64864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.