Introduction
The Double Balloon Endoscopic Platform (DBEP), DiLumen® EZ Glide (Lumendi Ltd, Maidenhead, UK), has been in clinical use since 2017. It has demonstrated safety and efficacy in facilitating diagnostic and complex therapeutic procedures in the colon, including patients with normal and surgically altered anatomy.
Aims & Methods
To evaluate the use of DiLumen® EZ Glide for diagnostic and therapeutic interventions within the small bowel.
The DBEP is a flexible overtube with two balloons at its distal end and is preloaded over a standard colonoscope. Once advanced into the sigmoid colon, the proximal (aft) balloon (rigidly attached to the overtube) is inflated to anchor the device within the colon. The device is then pulled back to shorten and straighten the sigmoid colon. Then the colonoscope is advanced to the next colonic segment, and the process of balloon inflation, retraction, and advancement is repeated until the cecum is reached and the assembly is directed through the ileocecal valve into the ileum. This technique is continued within the small bowel until the target lesion is reached for intervention.
Results
Seven patients (3 males, 4 females; mean age 59.7 ± 9.8 years) underwent ileal interventions using the DBEP. All procedures were technically successful (100%). The furthest advancement of the colonoscope was up to 6 feet proximal to the ileocecal valve. The mean size of small bowel lesions was 23.6 ± 11.4 mm.
Three patients had ileal polyps (30, 35 and 40 mm), all of which were removed en bloc: one by endoscopic mucosal resection (EMR) and two by endoscopic submucosal dissection (ESD). Pathology confirmed all polyps were benign, and no further treatment was required.
The remaining four patients had submucosal nodules (mean size 15.0 ± 4.1 mm, range 10–20 mm). Prior biopsies of this lesions covered by normal mucosa were non-diagnostic. All nodules were successfully removed en bloc (3 by ESD, 1 by EMR), and post-resection defects were closed using continuous suturing with the OverStitch™ endoscopic suturing system (Boston Scientific, Marlborough, MA, USA), delivered via the DBEP.
Histopathologic analysis revealed large B-cell lymphoma (1 patient) and well-differentiated neuroendocrine tumors (3 other patients). The lymphoma patient was treated conservatively with chemotherapy. All neuroendocrine tumor cases underwent robotic hemicolectomy with ileal resection. Pathological examination of surgical specimens revealed lymph node metastases (pN1) in all 3 patients.
Conclusion
Traditional endoscopic biopsy of ileal submucosal lesions does not provide adequate diagnostic value and cannot determine effective treatment plan. The DBEP significantly facilitates small bowel access and enables effective diagnostic and therapeutic endoscopic interventions inside the small bowel. In this early series, endoscopic excision of ileal lesions provided accurate histological diagnosis and directly influenced clinical management. Most importantly, our findings suggest that even early-stage (pT1 and pT2), well-differentiated ileal neuroendocrine tumors already had lymphatic spread, reinforcing the need for surgical resection despite complete local endoscopic excision.
Disclosure
Sergey Kantsevoy: Endosound - investor, Lumendi - consultant, equity, Medtronic - consultant, Olympus - consultant, Slater Endoscopy - consultant, equity, Vizballoons - consultant, equity.