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Trial registered on ANZCTR


Registration number
ACTRN12619000624189
Ethics application status
Approved
Date submitted
25/03/2019
Date registered
26/04/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic Management of Weight Regain post Gastric Bypass
Scientific title
Argon Plasma Coagulation and Endoscopic Suturing in the management of weight regain after gastric bypass surgery
Secondary ID [1] 297800 0
Nil Known
Universal Trial Number (UTN)
Not applicable
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Bariatric 312160 0
Weight regain post gastric bypass 312161 0
Obesity 312253 0
Condition category
Condition code
Diet and Nutrition 310706 310706 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endoscopic revision of a dilated gastrojejunal (GJ) stoma using endoluminal suturing or argon plasma coagulation (APC)

1) Endoluminal suturing involves the placement of sutures at the GJ stoma using a suturing platform that fixed on the end of a flexible endoscope, resulting in reduction of the lumen size

2. APC involves the use of a jet of ionized argon gas (plasma) that is directed through a catheter placed down the working channel of an endoscope. The probe is placed near the mucosa, and argon gas is emitted then ionized by a high voltage discharge resulting in controlled thermal injury to the stoma. Subsequent healing with fibrosis leads to narrowing of the GJ stoma.

This is a single-centre study (Endoscopy Unit, Gastroenterology and Hepatology Department, The Royal Brisbane and Women's Hospital, Queensland).
All procedures will be performed by 1 of 2 experienced endoscopists (Dr Patrick Walsh or Dr Jason Huang). Participants undergoing the procedure will require either a general anesthetic or propofol based sedation depending on patient factors, as per standard practice.
Eligible participants will be identified from the bariatric clinic and consented.
The gastroscopy (Olympus, Japan), overstitch device (Apollo Endosurgery, USA), APC system (ERBE, Germany) and biopsy forceps (Boston, USA) will be utilized.

Selecting therapy for participants based on the size of the GJ stoma:
A gastroscopy will be performed to allow initial inspection and measurement of the size of the GJ stoma using a jumbo biopsy forceps, with an 8mm opening. The opened biopsy forceps will be placed at the lumen of the GJ stoma, allowing direct measurement of the size. Participants with a stoma size of less than 15mm will be treated with APC, while other participants (i.e.: stoma size more than or equal to 15mm) will be treated with the overstitch device.

Participants will be routinely admitted into the ward for observation and discharge the following day. They are on small volume of clear fluids liquid on the day of the procedure. On discharge, the participants are placed on 2 weeks of very low energy diet meal replacements shakes. They will progress onto fluid diet and soft diet and gradually return to a normal diet over 8 weeks under the supervision of the dietitian in the bariatric clinic. Participants will then be reviewed in the bariatric clinic together with a dietitian at 3-, 6-, 9-, 12-, 18-, and 24- months. Follow up weight change, body mass index (BMI), percentage EWL and percentage of total weight loss will be measured in these clinic consultations. All participants will have a repeat endoscopy at 3 months to measure post intervention stoma size.
Intervention code [1] 314041 0
Treatment: Devices
Comparator / control treatment
60 participants from the Royal Brisbane and Women's Hospital with weight regain after gastric bypass (between January 2017 - January 2019) will be recruited for comparison.
Control group
Historical

Outcomes
Primary outcome [1] 319558 0
Weight change before and after the endoscopic revision. Digital scales will be used.
Timepoint [1] 319558 0
Baseline and at 3-, 6-, 9-, 12-, 18-, and 24- months after procedure
Secondary outcome [1] 368666 0
Not applicable
Timepoint [1] 368666 0
Not applicable

Eligibility
Key inclusion criteria
Inclusion criteria:
• Minimal post-operative period of 18 months;
• Regain of at least 10% of lowest weight attained post RYGB
• Anastomotic diameter of at least 12mm
• Able to provide consent for the procedure
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to give informed consent
• Women who are pregnant or intending to become pregnant in the 12 months after procedure
• Advanced medical comorbidities defined as
o Decompensated cirrhosis
o Cardiac failure with NYHA class III and IV symptoms
o COPD – Stage III and IV
o Kidney dysfunction on dialysis
o Active cancer undergoing treatment
o Cerebrovascular accident causing significant functional impairment
o Severe nutritional deficiencies
o alcoholism
o drug addiction
o recent neoplasia (less than 5 years)
o HIV seropositivity
• Anti-coagulant or anti-platelet agent, with the exception of Aspirin
• Allergy to medications used for anaesthetics

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2019
Actual
Date of last participant enrolment
Anticipated
9/03/2020
Actual
Date of last data collection
Anticipated
7/03/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302324 0
Hospital
Name [1] 302324 0
Department of Gastroenterology and Hepatology, The Royal Brisbane and Women's Hospital, Queensland
Country [1] 302324 0
Australia
Primary sponsor type
Hospital
Name
Department of Gastroenterology and Hepatology, The Royal Brisbane and Women's Hospital, Queensland
Address
Butterfield St
Royal Brisbane and Women's Hospital
Herston 4029 QLD
Country
Australia
Secondary sponsor category [1] 302205 0
None
Name [1] 302205 0
Address [1] 302205 0
Country [1] 302205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302997 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302997 0
Ethics committee country [1] 302997 0
Australia
Date submitted for ethics approval [1] 302997 0
17/08/2018
Approval date [1] 302997 0
14/02/2019
Ethics approval number [1] 302997 0
HREC/2018/QRBW/45035

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92118 0
Dr Patrick Walsh
Address 92118 0
Butterfield St
Royal Brisbane and Women's Hospital
Herston 4029, QLD
Country 92118 0
Australia
Phone 92118 0
+61 411706400
Fax 92118 0
Email 92118 0
paddyrwalsh@gmail.com
Contact person for public queries
Name 92119 0
Kath Bradley
Address 92119 0
Butterfield St
Royal Brisbane and Women's Hospital
Herston 4029, QLD
Country 92119 0
Australia
Phone 92119 0
+61 736460538
Fax 92119 0
Email 92119 0
Katherine.bradley@health.qld.gov.au
Contact person for scientific queries
Name 92120 0
Patrick Walsh
Address 92120 0
Butterfield St
Royal Brisbane and Women's Hospital
Herston 4029, QLD
Country 92120 0
Australia
Phone 92120 0
+61 411706400
Fax 92120 0
Email 92120 0
paddyrwalsh@gmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1718Study protocol    377265-(Uploaded-25-03-2019-12-50-36)-Study-related document.doc
1719Informed consent form    377265-(Uploaded-25-03-2019-12-50-54)-Study-related document.doc



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.