Ampullary AdenomasNCT05028465
EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension
A study testing Endoscopic Papillectomy and Endobiliary Radiofrequency Ablation in people with Ampullary Adenomas, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ampullary Adenomas
- What is being tested?
- Endoscopic Papillectomy and Endobiliary Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2013to 21 Nov 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven ampullary adenoma or adenocarcinoma with intraductal biliary extension ≥1cm who were deemed medically unfit for surgery or declined surgery
Who cannot join
- pancreatic invasion, lymph node invasion, distant metastasis, or coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension
Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.
Read the detailed description
Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.
- Conditions
- Ampullary Adenomas
- Being tested
- Endoscopic Papillectomy, Endobiliary Radiofrequency Ablation
- Keywords
- Endoscopic papillectomy, Radiofrequency ablation, Ampullary neoplasms, Intraductal biliary extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic PapillectomyProcedure or surgery
A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery.
Endobiliary Radiofrequency AblationProcedure or surgery
The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds.
| Study group | Role | What they receive |
|---|---|---|
| EP combined with RFA | Experimental | Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation Receives: Procedure: Endoscopic Papillectomy; Procedure: Endobiliary Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy
Measured: one year
Secondary outcomes (3)
Complete resection of ampullary adenomas
Complete resection of ampullary adenomas was confirmed when no residual tissue was found on ampullary and intraductal biopsies at the 3-month follow-up ERCP.
Measured: three months
Endoscopic success
Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.
Measured: six months
adverse events
adverse events such as bleeding, acute pancreatitis after procedure
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 Feb 2013
- Primary completion20 Nov 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ampullary AdenomasStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Jianfeng Yang, Dr., Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028465
- Sponsor's protocol ID
- 2021-08-118
- Status last verified
- Nov 2021
- First submitted
- 25 Aug 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watson RR, Muthusamy VR. Radiofrequency ablation for intraductal extension of ampullary neoplasms: Are we ready to feel the burn? Gastrointest Endosc. 2017 Jul;86(1):177-179. doi: 10.1016/j.gie.2016.12.022. No abstract available.
PubMed 28610856Camus 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 29660322Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
PubMed 29342492
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension
- ClinicalTrials.gov ID
- NCT05028465
- Acronym / sponsor ID
- 2021-08-118
- Conditions
- Ampullary Adenomas
- Keywords
- Endoscopic papillectomy, Radiofrequency ablation, Ampullary neoplasms, Intraductal biliary extension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 10 Feb 2013 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 31 Aug 2021 (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.
Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.
Detailed description
Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP combined with RFA | Experimental | Procedure: Endoscopic Papillectomy, Procedure: Endobiliary Radiofrequency AblationEndoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically proven ampullary adenoma or adenocarcinoma with intraductal biliary extension ≥1cm who were deemed medically unfit for surgery or declined surgery
Key exclusion criteria (1 listed)
- pancreatic invasion, lymph node invasion, distant metastasis, or coagulopathy.
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 |
|---|---|---|
| Endoscopic PapillectomyA snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery. | Procedure or surgery | EP combined with RFA |
| Endobiliary Radiofrequency AblationThe RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds. | Procedure or surgery | EP combined with RFA |
Primary outcome
Recurrence
Time frame: one year
Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy
3 secondary outcomes
Complete resection of ampullary adenomas
Time frame: three months
Endoscopic success
Time frame: six months
adverse events
Time frame: one months
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 23 Nov 2021.
- Background: PubMed 28610856Watson RR, Muthusamy VR. Radiofrequency ablation for intraductal extension of ampullary neoplasms: Are we ready to feel the burn? Gastrointest Endosc. 2017 Jul;86(1):177-179. doi: 10.1016/j.gie.2016.12.022. No abstract available.
- Background: 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.
- Background: PubMed 29342492Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
- 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.
Jianfeng Yang, Dr. principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Papillectomy and Endobiliary Radiofrequency Ablation in people with Ampullary Adenomas, run by First People's Hospital of Hangzhou at 1 site in China.
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 1 inclusion and 1 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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?
Recurrence (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 NCT05028465, which also lists 3 linked publications.
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 23 Nov 2021.