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Trial registered on ANZCTR


Registration number
ACTRN12621001534875
Ethics application status
Approved
Date submitted
6/05/2021
Date registered
10/11/2021
Date last updated
14/12/2022
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy of biodegradable biliary and pancreatic stents
Scientific title
To assess the feasibility and safety performance of the novel bio-degradable stent (ARCHIMEDES) in three patient groups: Duct to duct anastomotic strictures, hepatico-jejunal strictures and those that require post-endoscopy retrograde cholangiopancreatography (ERCP) pancreatitis prophylaxis (PEP).
Secondary ID [1] 304039 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary anastomotic stricture 321712 0
Hepatico-jejunal stricture 321713 0
Post-ERCP pancreatitis 321764 0
Condition category
Condition code
Oral and Gastrointestinal 319456 319456 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the feasibility and safety performance of the novel bio-degradable stent (ARCHIMEDES) in these three groups:
1. Duct to duct anastomotic stricture (20 patients)
2. Hepaticojejunal strictures (20 patients)
3. Post-ERCP pancreatitis prophylaxis (20 patients)

Patients referred to the investigators who meet the selection criteria will be invited to participate in this study. Prior to the study commencement the patient will be reviewed either by the transplant team or an interventional gastroenterologist in order to confirm the indication for the procedure (for duct to duct anastomotic stricture and hepaticojejunal stricture).

The procedures will be conducted by consultant gastroenterologists and fellow who have qualifications in ERCP and accredited by the Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy (CCRTGE).

Prior to study commencement, all endoscopists will receive a standardised 60-minute training module reviewing the study protocol, methods and data recording. The training module is designed specifically for this study. The study protocol will be available at the study centre.

Eligible patients will be approached and have the study explained to them by an investigator and be provided with a Patient Information Sheet. If an outpatient, they will be provided with at least 1 week to consider participation in the study. Inpatients will be given up to 24 hours to consider participation. Their surgery will proceed as planned regardless of their study participation. The consenting process will be carried out by a medical officer who is a researcher and independent from the attending medical team.

Post ERCP and biliary stent placement (groups 1 and 2), patients will undergo liver function tests at
• week 1
• week 2
• 1 month
• 3 months
• 6 months
• 9 months
• 12 months

Abdominal X-ray will be performed to ensure complete stent degradation at:
• 1 month
• 3 months
• 6 months



Endoscopic procedure
All endoscopic procedures will be performed with propofol-based deep sedation or general anaesthetic, with a consultant anaesthetist. A standard duodenoscope (Olympus, Japan) will be used for all procedures. Rectal indomethacin will be administered in patients where it is considered to be necessary (to prevent post procedure pancreatitis).

Group 1
Biliary cannulation will be performed with standard short guidewire and sphincterotome. If necessary, a sphincterotomy will be conducted. Prior to placement the biodegradable stent will be pre-activated by immersion in sterile saline for one minute. Insertion is performed over a guidewire through the working channel of the duodenoscope using a standard ERCP catheter. Insertion will be done under radiologic visualization. A cholangiogram will be obtained.

In patients with duct-to-duct biliary reconstruction, the stricture will be dilated with the aim to place stents to total diameter of 16Fr – 20Fr (2 x 8Fr stents or 10Fr). The stent size and number chosen will be determined based on findings at cholangiogram during ERCP. If the patient has undergone liver transplant within 8 weeks of ERCP, dilatation will not be performed and only a single stent will be placed. Total procedure time will be roughly 30 minutes.

Group 2
In patients with hepaticojejunostomies, double balloon ERCPs will be performed with a double balloon enteroscope (Fujinon, Japan) and dilations of the anastomosis will be carried out with the aim of placing stents up to 16 - 20Fr in diameter (again the size and number will be chosen based on findings at cholangiogram). If the patient has undergone liver transplant within 8 weeks of ERCP, dilatation will not be performed and only a single stent will be placed. Total procedure time will be roughly 60 minutes.

Group 3
In patients undergoing ERCP where a pancreatic stent is required for PEP prophylaxis (as per endoscopist discretion), a 6Fr pancreatic stent will be deployed. Total procedure time will be roughly 30 minutes.

Intervention code [1] 320389 0
Treatment: Devices
Intervention code [2] 320390 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327330 0
To assess the safety performance of a novel bio-degradable stent in duct to duct anastomotic strictures.

Safety assess as adverse events will be documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4.0). Any adverse events experiences by a patient will be discussed with a study Doctor and documented. Appropriate treatment and follow-up will be given to the patient. The study Investigators will consider if this event is related to the study procedure. Any adverse events will be reported to the Ethics Committee.
Timepoint [1] 327330 0
12 months post-ERCP and biodegradable stent placement
Primary outcome [2] 328796 0
To assess the safety performance of a novel bio-degradable stent in hepatico-jejunal strictures.

Safety assess as adverse events will be documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4.0). Any adverse events experiences by a patient will be discussed with a study Doctor and documented. Appropriate treatment and follow-up will be given to the patient. The study Investigators will consider if this event is related to the study procedure. Any adverse events will be reported to the Ethics Committee.
Timepoint [2] 328796 0
During 12 months post-ERCP and biodegradable stent placement
Primary outcome [3] 328797 0
To assess the safety performance of a novel bio-degradable stent in post-ERCP pancreatitis prophylaxis.

Safety assess as adverse events will be documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4.0). Any adverse events experiences by a patient will be discussed with a study Doctor and documented. Appropriate treatment and follow-up will be given to the patient. The study Investigators will consider if this event is related to the study procedure. Any adverse events will be reported to the Ethics Committee.
Timepoint [3] 328797 0
12 months post-ERCP and biodegradable stent placement
Secondary outcome [1] 394631 0
To determine the degradation time of the stents observed by abdominal radiograph (X-ray) in duct-to-duct anastomotic strictures.
Timepoint [1] 394631 0
At 1 month, 3 months and 6 months post-ERCP and biodegradable stent placement
Secondary outcome [2] 394632 0
To assess the requirement for second procedure to remove the stent in duct-to-duct anastomotic strictures will be assessed as a composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system

Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks followed by every 3 months post-ERCP f0r 12 months (face to face or telephone) reviewing clinical symptoms and results.
Timepoint [2] 394632 0
Blood tests at Post-ERCP week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays 1 month, 3 months and 6 months post-ERCP. Outpatient clinic review at week 4 post-ERCP followed by every 3 months.
Secondary outcome [3] 394633 0
To assess the rate of stricture resolution (clinical) of duct-to-duct anastomotic strictures will be assessed as a composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system,

Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks followed by every 3 months post-ERCP f0r 12 months (face to face or telephone) reviewing clinical symptoms and results.
Timepoint [3] 394633 0
Blood tests at Post-ERCP week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays 1 month, 3 months and 6 months post-ERCP. Outpatient clinic review at week 4 post-ERCP followed by every 3 months.
Secondary outcome [4] 394634 0
To determine the need for repeat stenting for stricture resolution of duct-to-duct anastomotic strictures will be assessed as a composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system

Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks followed by every 3 months post-ERCP f0r 12 months (face to face or telephone) reviewing clinical symptoms and results.

Timepoint [4] 394634 0
Blood tests at Post-ERCP week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays 1 month, 3 months and 6 months post-ERCP. Outpatient clinic review at week 4 post-ERCP followed by every 3 months.
Secondary outcome [5] 400406 0
To determine the degradation time of the stents observed by abdominal radiograph (X-ray) in hepatico-jejunal anastomotic strictures.
Timepoint [5] 400406 0
At 1 month, 3 months and 6 months post-ERCP and biodegradable stent placement
Secondary outcome [6] 400407 0
To determine the degradation time of the stents observed by abdominal radiograph (X-ray) in post-ERCP pancreatitis prophylaxis.
Timepoint [6] 400407 0
Week 2, 1 month and 3 months post-ERCP and biodegradable stent placement.
Secondary outcome [7] 400408 0
To assess the requirement for second procedure to remove the stent in hepatico-jejunal anastomotic strictures will be assessed as a composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system.

Blood tests at week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays at 1 month, 3 months and 6 months. Outpatient clinic review at week 4 followed by every 3 months reviewing clinical symptoms and results.
Timepoint [7] 400408 0
Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks post-ERCP followed by every 3 months post-ERCP f0r 12 months (face to face or telephone).
Secondary outcome [8] 400409 0
To assess the requirement for second procedure to remove the stent in post-ERCP pancreatitis prophylaxis will be assessed as composite of reviewing abdominal X-rays. X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system.
Timepoint [8] 400409 0
Abdominal X-rays at Post-ERCP week 1, month 1 and month 3. Outpatient review at 1 month and month 3 post-ERCP (telehealth or face to face).
Secondary outcome [9] 400410 0
To assess the rate of stricture resolution (clinical) of hepatico-jejunal anastomotic strictures will be assessed as a composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system.

Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks followed by every 3 months post-ERCP f0r 12 months (face to face or telephone) reviewing clinical symptoms and results.


Timepoint [9] 400410 0
Blood tests at post-ERCP week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays at 1 month, 3 months and 6 months post-ERCP. Outpatient clinic review at week 4 post-ERCP followed by every 1 - 3 months thereafter.
Secondary outcome [10] 400411 0
To determine the need for repeat stenting for stricture resolution of hepatico-jejunal anastomotic strictures will be assessed as composite of reviewing abdominal X-rays and accessing pathology tests. Blood tests and X-ray results will be sent automatically by electronic medical records to our corresponding facility for review. This will be performed primarily by accessing patient medical records on our electronic medical records system.

Patients will also be reviewed in the outpatient setting (liver transplant clinic) 4 weeks followed by every 3 months post-ERCP f0r 12 months (face to face or telephone) reviewing clinical symptoms and results.


Timepoint [10] 400411 0
Blood tests at Post-ERCP week 1, 1 month, 3 months, 6 months, 9 months and 12 months. Abdominal X-rays at 1 month, 3 months and 6 months. Outpatient clinic review at week 4 followed by every 1 - 3 months.

Eligibility
Key inclusion criteria
Clinical criteria (1 required)
A. Patients with clinical indication for ERCP with a duct to duct anastomotic stricture or Hepaticojejunal stricture
Or
B. Those requiring pancreatic duct stent placement for post ERCP pancreatitis prophylaxis.

Other criteria:
Symptoms or signs: jaundice, cholangitis
Age 18 years old and above
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contra-indication for endoscopy
Pregnancy
Patients who had undergone any treatment to the stricture in the last 6 months
Inability to pass a guidewire through stricture
Malignant stricture
Multiple concomitant bile duct strictures
Stricture length > 8cm
Anticoagulant therapy that cannot be discontinued prior to procedure

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participant groups will be categorized by indication for stenting as described in each group heading previously.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
60 patients in total are required to assess efficacy in each group. Data will be analysed descriptively. Baseline characteristics of the patient population, BE characteristics, technical details, and procedure outcomes will be summarised as means (SD) or medians (with interquartile range [IQR] and range) for continuous data, and as frequencies and proportions for categorical data. All statistical analysis will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/12/2021
Actual
6/12/2021
Date of last participant enrolment
Anticipated
13/05/2024
Actual
Date of last data collection
Anticipated
12/05/2025
Actual
Sample size
Target
60
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19224 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 33797 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308422 0
Hospital
Name [1] 308422 0
Royal Prince Alfred Hospital
Country [1] 308422 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Rd, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 309298 0
None
Name [1] 309298 0
Address [1] 309298 0
Country [1] 309298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308383 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 308383 0
Ethics committee country [1] 308383 0
Australia
Date submitted for ethics approval [1] 308383 0
12/03/2021
Approval date [1] 308383 0
30/06/2021
Ethics approval number [1] 308383 0
X20-0514

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

Contacts
Principal investigator
Name 110522 0
A/Prof Payal Saxena
Address 110522 0
Royal Prince Alfred Hospital
AW Morrow, Gastroenterology and Hepatology
50 Missenden Road
Camperdown
NSW
2050
Country 110522 0
Australia
Phone 110522 0
+61 407 436 653
Fax 110522 0
Email 110522 0
[email protected]
Contact person for public queries
Name 110523 0
Kevin Kyung Ho Choi
Address 110523 0
Royal Prince Alfred Hospital
AW Morrow, Gastroenterology and Hepatology
50 Missenden Road
Camperdown
NSW
2050
Country 110523 0
Australia
Phone 110523 0
+61401945726
Fax 110523 0
Email 110523 0
[email protected]
Contact person for scientific queries
Name 110524 0
Kevin Kyung Ho Choi
Address 110524 0
Royal Prince Alfred Hospital
AW Morrow, Gastroenterology and Hepatology
50 Missenden Road
Camperdown
NSW
2050
Country 110524 0
Australia
Phone 110524 0
+61401945726
Fax 110524 0
Email 110524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification and individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal as well as case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Review articles and IPD meta-analysis
How or where can data be obtained?
Please contact [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
New Record*Basic resultsNo V08.10.2024 Archimedes Excel.xlsx

Documents added automatically
No additional documents have been identified.