Adenoma, Bile DuctendoHPBNCT02825524
Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy
A study testing Habib™ EndoHBP in people with Adenoma, Bile Duct, run by Hôpital Cochin.
Trial summary
The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenoma, Bile Duct
- What is being tested?
- Habib™ EndoHBP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Mar 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of lesions of low-grade dysplasia (LGD) or high grade (HGD) in the common bile duct, confirmed by two pathological readings in relation to residual adenomatous tissue into the common bile duct after endoscopic ampullectomy for ampullome conducted in the previous year
- Lack of residual adenomatous lesion on the duodenal side after ampullectomy and possibly additional procedures (endoscopic mucosal resection or argon plasma). (excluding other duodenal adenomatous lesions in the context of familial adenomatous polyposis
- Consultative multidisciplinary digestive cancer meeting confirming the indication of treatment with endo-biliary radio-frequency
- Dysplastic lesions extending over 20 mm length maximum in the common bile duct
- Patients aged ≥ 18 years old and ≤ 85 years old
- Patients who consented to participate in the study
Show all 9Show fewer
- No anesthesia contraindication (ASA 1,2,3)
- Patient affiliated to a social security scheme (beneficiary or legal)
- Lack of pregnancy and contraception being women age procreate
Who cannot join
- Lesions of invasive carcinoma in a patient whose clinical condition allows to consider a pancreaticoduodenectomy
- Endo-biliary dysplastic lesions diffuse or multifocal
- Presence of non extractable metal biliary expansive prosthesis
- History of pancreaticoduodenectomy or hepaticojejunostomy anastomosis
- Impassable stenosis of the common bile duct
- Severe coagulopathy, thrombocytopenia < 75,000 G/L , Clopidogrel treatment impossible to stop temporarily
Show all 9Show fewer
- Anesthesia contraindication ( ASA 4)
- Pace maker or other active implantable medical device
- Inability to obtain informed consent
About this study
Official title: Efficacy and Safety of Endobiliairy Radiofrequency (Probe Habib TM EndoHPB) for the Destruction of Residual Endo Biliairy Dysplastic Buds After Endoscopic Ampullectomy: Prospective Multicenter Study
The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
Read the detailed description
Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.
- Conditions
- Adenoma, Bile Duct
- Being tested
- Habib™ EndoHBP
- Medical subject headings
- Adenoma, Bile Duct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habib™ EndoHBPDevice
During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.
| Study group | Role | What they receive |
|---|---|---|
| Endobiliary radiofrequency | Experimental | Not described Receives: Device: Habib™ EndoHBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of residual neoplasia
Measured: one year
Secondary outcomes (8)
presence of low grade dysplasia or high grade dysplasia or invasive carcinoma
Measured: 6 months
number of surgery
Measured: one year
fever
Measured: 48 hours post endoscopic procedure
pain
Visual Analogue Scale
Measured: 48 hours post endoscopic procedure
bleeding
hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin
Measured: 48 hours post endoscopic procedure
acute pancreatitis
pain and increased of lipase more than 3 fold
Measured: 48 hours post endoscopic procedure
cholangitis
fever and abnormal hepatic blood tests
Measured: 48 hours post endoscopic procedure
perforation
pneumoperitoneum, retropneumoperitoneum, pneumothorax
Measured: 48 hours post endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startNov 2012
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma, Bile DuctStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Cochin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic PRAT, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825524
- Sponsor's protocol ID
- 2011-A00721-40
- Acronym
- endoHPB
- Status last verified
- Aug 2017
- First submitted
- 15 Jun 2016
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Camus M, Napoleon B, Vienne A, Le Rhun M, Leblanc S, Barret M, Chaussade S, Robin F, Kaddour N, Prat F. Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study. Gastrointest Endosc. 2018 Sep;88(3):511-518. doi: 10.1016/j.gie.2018.04.2332. Epub 2018 Apr 13.
PubMed 29660322
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endobiliairy Radiofrequency (Probe Habib TM EndoHPB) for the Destruction of Residual Endo Biliairy Dysplastic Buds After Endoscopic Ampullectomy: Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02825524
- Acronym / sponsor ID
- endoHPB / 2011-A00721-40
- Conditions
- Adenoma, Bile Duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hôpital CochinUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
Detailed description
Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endobiliary radiofrequency | Experimental | Device: Habib™ EndoHBP |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of lesions of low-grade dysplasia (LGD) or high grade (HGD) in the common bile duct, confirmed by two pathological readings in relation to residual adenomatous tissue into the common bile duct after endoscopic ampullectomy for ampullome conducted in the previous year
- Lack of residual adenomatous lesion on the duodenal side after ampullectomy and possibly additional procedures (endoscopic mucosal resection or argon plasma). (excluding other duodenal adenomatous lesions in the context of familial adenomatous polyposis
- Consultative multidisciplinary digestive cancer meeting confirming the indication of treatment with endo-biliary radio-frequency
- Dysplastic lesions extending over 20 mm length maximum in the common bile duct
- Patients aged ≥ 18 years old and ≤ 85 years old
Key exclusion criteria (9 listed)
- Lesions of invasive carcinoma in a patient whose clinical condition allows to consider a pancreaticoduodenectomy
- Endo-biliary dysplastic lesions diffuse or multifocal
- Presence of non extractable metal biliary expansive prosthesis
- History of pancreaticoduodenectomy or hepaticojejunostomy anastomosis
- Impassable stenosis of the common bile duct
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 |
|---|---|---|
| Habib™ EndoHBPDuring an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib. | Device | Endobiliary radiofrequency |
Primary outcome
number of residual neoplasia
Time frame: one year
8 secondary outcomes
presence of low grade dysplasia or high grade dysplasia or invasive carcinoma
Time frame: 6 months
number of surgery
Time frame: one year
fever
Time frame: 48 hours post endoscopic procedure
pain
Time frame: 48 hours post endoscopic procedure
bleeding
Time frame: 48 hours post endoscopic procedure
acute pancreatitis
Time frame: 48 hours post endoscopic procedure
cholangitis
Time frame: 48 hours post endoscopic procedure
perforation
Time frame: 48 hours post endoscopic procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Derived from this study: PubMed 29660322Camus M, Napoleon B, Vienne A, Le Rhun M, Leblanc S, Barret M, Chaussade S, Robin F, Kaddour N, Prat F. Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study. Gastrointest Endosc. 2018 Sep;88(3):511-518. doi: 10.1016/j.gie.2018.04.2332. Epub 2018 Apr 13.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Habib™ EndoHBP in people with Adenoma, Bile Duct, run by Hôpital Cochin.
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 9 inclusion and 9 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: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of residual neoplasia (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825524, which also lists 1 linked publication.
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 28 Aug 2017.