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.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is safety i.e. rate of adverse events such as pancreatitis,
bleeding, cholangitis, perforation, and papillary stenosis (at 9 months).
Secondary outcome
Curative resection rate at 3 and 9 months follow-up is included as secondary
outcome.
Background 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.
Study objective
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.
Study design
A prospective pilot cohort study in two centers e.g. Westmead Hospital, Sydney,
Australia and Amsterdam UMC, Amsterdam, the Netherlands.
Intervention
Thermal ablation of resection margins by STSC and biliary orifice by cystotome.
Study burden and risks
STSC did not lead to more adverse events after resection of a duodenal adenoma
and is therefore considered safe. A biliary stricture is commonly reported
after RFA. Although the use of a cystotome seems safer, a fully covered metal
stent is placed afterwards to prevent papillary stenosis. Pancreatitis is
common after conventional endoscopic papillectomy, to prevent an increased risk
of pancreatitis after thermal ablation, it is only performed after placement of
a pancreatic stent (in case of normal pancreatic duct anatomy). The rest of the
proposed treatment algorithm is primarily based on recent Delphi consensus
algorithm and should be considered standard care. Follow-up is according to the
proposed follow-up of patients with high-grade dysplasia. Additionally patients
will be called 30 days after the procedure to assess possibly related adverse
events. If out hypothesis is correct patient will benefit form a lower
recurrence rate and consequently less procedures and reduced risk on
complications associated with these procedures.
Boelelaan 1118
Amsterdam 1081 HZ
NL
Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79410.029.21 |