Colorectal AdenomaHADRIANNCT05517369
Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm
A study testing Hybrid ESD+ in people with Colorectal Adenoma, run by Wuerzburg University Hospital at 9 sites in 2 countries.
Trial summary
This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Hybrid ESD+
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Mar 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
- Ablation medically indicated and possible (coagulation, etc. - as determined by the center)
Who cannot join
- Age < 18 years
- Pedunculated lesion (Paris0-Ip)
- Size of the lesion <2cm or >3cm
- Pregnant and breastfeeding women
- Patient not capable of informed consent / consent not possible
- Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma
Show all 13Show fewer
- Non-lifting sign / known recurrence after previous therapy
- Impassable stenosis in the colon / rectum
- Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection
- As per contraindications from the AWC \& LiftUp Instructions for Use:
- The AWC is not to be used if flexible-endoscopic procedures are contraindicated.
- The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.
- LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany7 sites
Mathilden Hospital Herford
Herford, 32052
Agaplesion Diakonie Kliniken Kassel
Kassel, 34119
Klinikum Ludwigsburg
Ludwigsburg, 71640
St. Franziskus Hospital Münster
Münster, 48145
Universitätsklinikum Ulm
Ulm, 89081
Rems-Murr-Klinikum Winnenden
Winnenden, 71364
Universitätsklinik Würzburg
Würzburg, 97080
Switzerland2 sites
Inselspital Bern
Bern, 3010
Stadtspital Waid
Zurich, 8037
About this study
Official title: Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.
This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.
Read the detailed description
There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure.
Conventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely.
A possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above.
The higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions.
In this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution.
Methodological and clinical parameters are recorded. After 4 weeks, the patients are contacted by telephone to record possible late effects.
If an endoscopic control is performed after 6 months (according to the guideline or according to the investigator), the findings are also recorded.
- Conditions
- Colorectal Adenoma
- Being tested
- Hybrid ESD+
- Keywords
- Hybrid-ESD+, Endoscopic Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid ESD+Procedure or surgery
Injection of the Lift Up solution, followed by circumcision of the lesion using a snare tip or ESD knife. Using an additional working channel (AWC), the lesion is resected using a grasper and snare.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid-ESD+ | Experimental | All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method. Receives: Procedure: Hybrid ESD+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+
In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination
Measured: after 14 days
Secondary outcomes (9)
Complication rate (perforations, bleeding)
Perforation: dehiscence of the muscularis propria diagnosed during or after resection.
Hemorrhage:
- Clinically significant post-endoscopic bleeding (CSPEB). Bleeding from the ablation site with hematochezia after completion of index colonoscopy
- Intraprocedural bleeding (IPB). Percent, defined as bleeding lasting > 60 seconds during intervention necessitating therapy
Measured: up to 4 weeks
Recurrence rate
Rate of adenoma residue and/or adenoma recurrence in percent after 6 months. This is determined by the colonoscopic and histologic findings from 2 biopsies from the scar or resection specimen.
Measured: 6 months
Procedural parameters - Intervention duration
Intervention duration (time range from injection to complete resection)
Measured: 1 day
Procedural parameters - Cleanliness of the colon
Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9)
Measured: 1 day
Localization of polyp
Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum)
Measured: 1 day
Polyp size
Polyp diameter in mm
Measured: 1 day
Polyp morphology
according to paris classification
Measured: 1 day
Polyp histology
histological examination (tubular, tubulovillous, villous)
Measured: 7 days
Duration of hospital stay
Time frame from first day to discharge
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Mar 2023
- Primary completionApr 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: No participants fitting into the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Waid City Hospital, Zurich, University Hospital Ulm, Rems-Murr-Klinikum Winnenden, Insel Gruppe AG, University Hospital Bern, Klinikum Ludwigsburg, Mathilden Hospital Herford, St. Franziskus Hospital Münster, Agaplesion Kliniken Kassel, Ovesco Endoscopy AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517369
- Sponsor's protocol ID
- Brand_HADRIAN_10_08_2022
- Other IDs
- WHO Universal Trail Number
- Acronym
- HADRIAN
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.
- ClinicalTrials.gov ID
- NCT05517369
- Acronym / sponsor ID
- HADRIAN / Brand_HADRIAN_10_08_2022
- Conditions
- Colorectal Adenoma
- Keywords
- Hybrid-ESD+, Endoscopic Resection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants fitting into the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Waid City Hospital, Zurich, University Hospital Ulm, Rems-Murr-Klinikum Winnenden, Insel Gruppe AG, University Hospital Bern, Klinikum Ludwigsburg, Mathilden Hospital Herford, St. Franziskus Hospital Münster, Agaplesion Kliniken Kassel, Ovesco Endoscopy AG
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.
Detailed description
There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure.
Conventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely.
A possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above.
The higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions.
In this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution.
Methodological and clinical parameters are recorded. After 4 weeks, the patients are contacted by telephone to record possible late effects.
If an endoscopic control is performed after 6 months (according to the guideline or according to the investigator), the findings are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid-ESD+ | Experimental | Procedure: Hybrid ESD+All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
- Ablation medically indicated and possible (coagulation, etc. - as determined by the center)
Key exclusion criteria (13 listed)
- Age < 18 years
- Pedunculated lesion (Paris0-Ip)
- Size of the lesion <2cm or >3cm
- Pregnant and breastfeeding women
- Patient not capable of informed consent / consent not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid ESD+Injection of the Lift Up solution, followed by circumcision of the lesion using a snare tip or ESD knife. Using an additional working channel (AWC), the lesion is resected using a grasper and snare. | Procedure or surgery | Hybrid-ESD+ |
Primary outcome
R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+
Time frame: after 14 days
In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination
9 secondary outcomes
Complication rate (perforations, bleeding)
Time frame: up to 4 weeks
Recurrence rate
Time frame: 6 months
Procedural parameters - Intervention duration
Time frame: 1 day
Procedural parameters - Cleanliness of the colon
Time frame: 1 day
Localization of polyp
Time frame: 1 day
Polyp size
Time frame: 1 day
Polyp morphology
Time frame: 1 day
Polyp histology
Time frame: 7 days
Duration of hospital stay
Time frame: up to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid ESD+ in people with Colorectal Adenoma, run by Wuerzburg University Hospital at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+ (time frame: after 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.