Cystic Tumors of the Pancreas Clinical Trial
Official title:
Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
Cystic lesions of the pancreas are defined as round, fluid-filled structures within the
pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging
modalities for various indications, such lesions are now detected in nearly 20% of abdominal
imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum
of histopathologic entities and biologic behavior, ranging from benign to malignant.
Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic
lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to
differentiate each cystic lesion and make a management plan since cystic lesions that are
relatively common and asymptomatic may possess malignant potential. Although inflammatory
pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with
cystic tumors accounting for the remaining,10 the latter may occur much more frequently than
traditionally estimated.
To date, surgical resection is generally recommended for malignant and potentially malignant
lesions. However, surgical resection of the pancreas still carries substantial morbidity and
sometimes mortality, especially for the cystic lesion located in the head portion.
Therefore, management should be individualized by risk-benefit analysis for each patient.
Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas
reported that complete resolution was achieved in only one-third of patients even though
epithelial lining ablation was demonstrated in all resected specimens. Therefore, more
effective treatment modalities or ablation agents are required to improve treatment
responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used
for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16
EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer.
Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not
yet been reported, it is reasonable to suggest that such an approach may have an additive
effect on ablation of the epithelial lining of cystic tumor when combined with ethanol
lavage.
Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent
on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to
exert its effect longer when instilled within a closed cavity such as a cyst. The
hydrophobic and viscous nature of paclitaxel may reduce the possibility of it leaking
through a puncture site and causing complications.
The present study evaluated safety, feasibility and response following EUS-guided ethanol
lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment