A new long-range through-the-scope balloon applicator for photodynamic therapy in the esophagus and cardia

Abstract

Background and study aims: Photodynamic therapy (PDT) is a new local, endoscopically controlled therapeutic technique based on the sensitization of malignant and precancerous lesions prior to light-induced tissue destruction. PDT of Barrett's esophagus with severe dysplasia, or of mucosal carcinomas and superficial squamous-cell cancer of the esophagus, requires light application devices allowing homogeneous illumination of the tissue surface in spite of esophageal motility and respiratory movement. On the basis of a commercially available through-the-scope balloon system, we developed a long-range light applicator for homogeneous and circumferential irradiation during PDT, and describe here the initial clinical experience with the device.

Patients and methods: The new balloon applicator consists of a flexible cylindrical diffuser fiber with a length of up to 10 cm, depending on the lesion to be illuminated, and an inflatable balloon based on the type of balloon used for esophageal dilation. The balloon is made of a transparent polyurethane membrane with negligible absorption (<5%) at lambda = 600-700 nm, and it can be positioned through the biopsy channel of a conventional endoscope, with direct endoscopic visualization of the targeted lesion. The light intensity distribution perpendicular to the optical axes of the diffuser was measured for red laser light (lambda = 632.8 nm) and for green laser light (lambda = 542 nm). The study of photodynamic treatment included two women and four men (aged 48-79 years) with histologically proved high-grade dysplasia (n = 2) or mucosal cancer in Barrett's esophagus (n = 2) and superficial squamous-cell cancer (SCC) (n = 2), who had undergone EUS staging showing uT0 or uT1N0. Laser light irradiation was conducted after oral ingestion of 5-aminolevulinic acid (5-ALA) or intravenous administration of meta-(tetrahydroxyphenyl)chlorin (mTHPC).

Results: Both in vitro and in vivo, precise positioning of the new application system at the targeted tissue and homogeneous illumination were feasible, safe and effective. The total efficiency of transmitted light at wavelengths of lambda = 632.8 nm and lambda = 542 nm was 85-90%. A high degree of homogeneity was measured with applicator lengths of between 15 mm and 95 mm, and the maximum deviation from the mean intensity extended over a range of 40% over the total length of 80 mm. High-grade dysplasia was eradicated in all patients, and in addition mucosal cancer was successfully destroyed in three-quarters of them, requiring an average of 1.3 treatment sessions, with a mean follow-up of 12 months (range 10-15 months).

Conclusions: This centering balloon system may in the future be capable of improving light application techniques during esophageal photodynamic therapy, making PDT a more reliable alternative modality for minimally invasive treatment of high-grade dysplasia and early Barrett's esophagus or squamous-cell carcinoma, as compared with esophagectomy.