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Trial registered on ANZCTR


Registration number
ACTRN12618000696291
Ethics application status
Approved
Date submitted
25/12/2017
Date registered
30/04/2018
Date last updated
30/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Placement of Percutaneous Endoscopic Gastrostomy in Ambulatory Regimen in Selected Patients with Head and Neck Tumors: Feasibility and safety evaluation
Scientific title
Placement of Percutaneous Endoscopic Gastrostomy in Ambulatory Regimen in Selected Patients with Head and Neck Tumors: Feasibility and safety evaluation
Secondary ID [1] 293691 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 305976 0
Head and Neck 305977 0
Percutaneous endoscopic gastrostomy (PEG) 305979 0
Condition category
Condition code
Cancer 305171 305171 0 0
Head and neck
Public Health 305732 305732 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEG placement is performed by two gastroenterologists under deep sedation performed by an anesthesiologist. The procedure takes about 15 minutes and it provides the patient a feeding tube conecting the gastric cavity to the outside for enteral nutrition. The ambulatory participant will be discharged without need for hospitalization 4 hours after the procedure. Oral analgesia for ambulatory (acetaminophen 1g every 8 hous, as needed) will be provided with a prescription provided by the gastroenterologist after patient evaluation, prior to discharge. The patient or a care-guiver will be responsible for oral analgesia administration.
Intervention code [1] 299944 0
Treatment: Devices
Comparator / control treatment
PEG placement is performed by two gastroenterologists under deep sedation performed by an anesthesiologist. The procedure takes about 15 minutes and it provides the patient a feeding tube conecting the gastric cavity to the outside for enteral nutrition. PEG placement on an inpatient basis with an hospitalization for 24 hours after PEG placement is the current practice. The patient is discharged 24 hours after the procedure.
IV analgesia is provided by a nurse, in the hospital inpatient service, with a prescription provided by the gastroenterologist after PEG placement.
Control group
Active

Outcomes
Primary outcome [1] 304325 0
Feasibility of percutaneous endoscopic gastrostomy (PEG) placement in ambulatory participants will be confirmed if patient:
a) Is discharged without abdominal pain;
b) Is tolerating liquids through PEG tube 4 hours after procedure;
c) Does not return for medical evaluation in the first 24h after procedure.
Timepoint [1] 304325 0
24h after procedure
Secondary outcome [1] 341578 0
Number of patients that require medical (antibiotics or IV analgesia), endoscopic or surgical treament in the first 24hours after procedure will be assesses from medical records.
Timepoint [1] 341578 0
24h after procedure
Secondary outcome [2] 341579 0
Number of early complications (peritonitis, infection, extrusion, "burried bumper syndrome") occurring in the first week after PEG procedure will be assessed from medical records.
Timepoint [2] 341579 0
one week after procedure

Eligibility
Key inclusion criteria
Patients with head and neck tumors referenced for PEG placement
ASA Class <IV
Performance Scale ECOG Status <3
Have quick access to the IPO Urgency (<1h by car) within 24 hours after the procedure.
Have a caregiver within the first 24 hours after the procedure at your residence.
Age> 18 years and <80 years
Ability to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of the patient
Inability to provide informed consent
Need for dilation prior to PEG placement
Impossibility to access the IPO Urgency in the first 24 hours after the procedure in a period less than 1h
Contraindications for PEG placement (patients unable to take PEG, chronic liver disease, presence of ascites, thrombocytopenia (<50,000 platelets), coagulopathy (INR> 1.5).
Associated pathology: acute myocardial infarction and / or stroke for less than 1 year; severe tachyarrhythmia under treatment for less than 6 months; cardiac stent (s) placed for less than one year with a need for discontinuation of antiplatelet agents; severe renal insufficiency (creatinine greater than or equal to 2); severe respiratory insufficiency with SaO2 less than or equal to 90% without oxygen supply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Assuming the rates of complications (similar to those published in the literature) of 15% or 20% in both groups (outpatient and inpatient setting), the number of patients that would need to be included to establish non-interiority with a power of 80% and a significance level of 5% is 89 or 112 patients in each arm, respectively, in order to exclude a 15% difference favorable to the rate of hospitalized PEG complications. With 200 PEGs placed in 2016, the inclusion period is estimated to be 18 months.
A safety committee will be appointed, consisting of a gastroenterologist and a nurse not involved in the placement of the PEGs, who will monitor the results monthly. A difference of more than 15% in the complications of either cohort will be the criterion for completing the trial.
The statistical analysis will be done with the program SPSS Statistics 23 (IBM).
Continuous variables will be expressed as means and standard deviations or medians with the interquartile limits and compared by Student's or Wilcoxon's t tests. 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, a logistic regression analysis will be done. A value of p <0.05 will be considered statistically significant.
All changes to the planned analysis will be documented, reported and justified in the final presentation of the results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9465 0
Portugal
State/province [1] 9465 0

Funding & Sponsors
Funding source category [1] 298296 0
Other Collaborative groups
Name [1] 298296 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Address [1] 298296 0
Rua Prof Lima Basto
1099-023 Lisboa
Country [1] 298296 0
Portugal
Primary sponsor type
Individual
Name
Sandra Faias
Address
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country
Portugal
Secondary sponsor category [1] 297411 0
Individual
Name [1] 297411 0
Luis Medeiros
Address [1] 297411 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Anesthesiology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country [1] 297411 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299296 0
Comissão de Ética para Saúde do Instituto Português de Oncologia de Lisboa
Ethics committee address [1] 299296 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Ethics committee country [1] 299296 0
Portugal
Date submitted for ethics approval [1] 299296 0
Approval date [1] 299296 0
22/11/2017
Ethics approval number [1] 299296 0
UIC/1142

Summary
Brief summary
This study will allow to evaluate prospectivelly the possibility of outpatient PEG placement procedure in a cohort of patients with head and neck tumors with good status and low or moderate surgical anesthetic risk. PEG placement on outpatient basis will be helpful for patients, caregivers and the hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79950 0
Dr Sandra Faias
Address 79950 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country 79950 0
Portugal
Phone 79950 0
+351914310209
Fax 79950 0
Email 79950 0
sandrarfaias@hotmail.com
Contact person for public queries
Name 79951 0
Dr Sandra Faias
Address 79951 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country 79951 0
Portugal
Phone 79951 0
+351914310209
Fax 79951 0
Email 79951 0
sandrarfaias@hotmail.com
Contact person for scientific queries
Name 79952 0
Dr Sandra Faias
Address 79952 0
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Gastroenterology Department
Rua Prof Lima Basto
1099-023 Lisboa
Country 79952 0
Portugal
Phone 79952 0
+351914310209
Fax 79952 0
Email 79952 0
sandrarfaias@hotmail.com

No data has been provided for results reporting
Summary results
Not applicable