Clinical trial NCT05339607: Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
Official title: Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Adenoma
Keywords: Endoscopic papillectomy
Recurrence
STSC
Intraductal ablation
Cystotome
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
First posted: 2022-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.

Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.


Eligibility criteria: Inclusion Criteria:

* Papillary adenoma which seems suitable for curative endoscopic resection.
* 18 years or older.
* Capable of providing written and oral informed consent.

Exclusion Criteria:

* Patients with intraductal extension of \>1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.
* Failure to place a PD stent in patients with normal pancreatic duct anatomy.
* Refusal to provide informed consent.

Primary outcomes:
measure: Safety (rate of adverse events)
timeFrame: During 9 months follow-up
Secondary outcomes:
measure: Curative resection rate
timeFrame: 3 and 9 months
measure: Additional yield of EUS prior to resection.
timeFrame: Prior to intervention.
measure: Effect of hemospray as first modality in case of post procedural bleeding in need of intervention.
timeFrame: Delayed bleeding is expected not more than 30 days after the procedure
measure: Individual components of the primary outcome.
timeFrame: During 9 months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location VUmc
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Rogier P Voermans, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: