The objective of this study is to investigate the amount of clinically relevant complications (defined by Clavien-Dindo score 3 or higher) caused by IRE in patients with locally advanced, non-resectable, non-metastasized, pancreatic cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Clavien-Dindo score 3 or higher complications, these are
defined as complications leading to re-intervention (endoscopic, surgical or
radiological), admission to the intensive care unit, or mortality.
Secondary outcome
Secondary endpoints: success rate of completing the procedure, duration of the
procedure, intraprocedural complications, time to functional recovery, length
of hospital stay, complications, readmissions, ablation effect as recorded on
cross-sectional imaging, and survival (2 year survival, median survival,
progression free survival).
Background summary
Pancreatic adenocarcinoma is a devastating disease with a 2-year overall
survival below 10%. Although surgical resection offers the only chance for
cure, 80% of patients present with unresectable disease because of local
progression or metastases. The treatment for these patients is palliative
chemotherapy, radiotherapy, or both, but offers only marginal survival
advantage. Recently, irreversible electroporation (IRE), a non-thermal ablation
technique, has been suggested as a novel treatment for the 40% of patients with
locally advanced pancreatic cancer, without metastases. Some clinical data
suggest that IRE, when performed during surgical exploration, may improve
overall survival with 9 months with limited risks of complications.
Study objective
The objective of this study is to investigate the amount of clinically relevant
complications (defined by Clavien-Dindo score 3 or higher) caused by IRE in
patients with locally advanced, non-resectable, non-metastasized, pancreatic
cancer.
Study design
A phase II safety study
Intervention
IRE during open surgery (during the same procedure as intended for resection or
confirmation of unresectability).
Study burden and risks
Based on current literature (one prospective study, n=54) the estimated gain in
overall survival is 9 months (from 11 to 20 months). According to the current
literature clinically relevant complications are expected in up to 17% of
procedures with 1-2% mortality.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Capable of providing written and oral informed consent
- Physically fit to undergo explorative laparotomy
- Pancreatic cancer confirmed with pathology (either pre- or intraoperative, pathological diagnosis must be either pancreatic adenocarcinoma or non-intestinal cholangiocarcinoma located in the pancreas) and non resectability because of locally advanced growth (stage III) during surgical exploration
- One of the following:
* Potentially resectable panreatic cancer based on imaging and planned for surgical exploration with intend for resection, this includes 2 groups of patients
* Patients with resectable disease at primary evaluation but are considered non-resectable during surgical exploration
$ Patients with initially non-resectable disease because of locally advanced pancreatic cancer without metastases, who have stable or regressive (non-metastasized) disease after 3 months of chemotherapy
* Locally advanced pancreatic cancer based on imaging without options for non-operative drainage of stomach and bileducts and therefore planned for surgical exploration with intend for bypass surgery
Exclusion criteria
- Resectable pancreatic cancer during explorative laparotomy
- Presence of metastatic disease (peritoneal, liver or other)
- Pathological diagnosis of intestinal-type cholangiocarcinoma
- History of cardiac arrhythmia*s
* Sinus tachycardia (BPM>100)
* Sick sinus syndrome
* Sinoatrial exit block
* AV block
* Sinus node reentry
* Presence of a pacemaker or defibrillator
- Recent history of myocardial infarction
- History of epilepsy
- Partial portal vein thrombosis
- Both narrowing (sclerosis) of the portal vein and a reduced diameter of either the common hepatic artery, celiac trunc or superior mesenteric artery of >50%
Design
Recruitment
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 | NL44713.018.13 |