Introduction

Screening colonoscopy has become the gold standard in discovery and removal of colonic polyps and prevention of colon cancer. However, in 13.1-25.8% of patients colonoscopy was not completed and cecal intubation was not achieved.^1-3 DiLumen® (Lumendi LLC, Westport CT, USA) double balloon endoscopic platform was developed to facilitate endoscopic interventions in gastrointestinal tract.

Aims & Methods

Aim: To evaluate use of DiLumen® to facilitate difficult colonoscopy.
Methods: DiLumen® is a flexible overtube with 2 balloons on its distal end. One (Aft) balloon is rigidly attached to the overtube and a second (For) balloon can be advanced forward or pulled back using 2 push rods moved by a slider located on the handle of DiLumen®. The assembled platform is pre-loaded on top of any colonoscope and introduced into the rectum. The colonoscope-DiLumen® assembly is advanced through sigmoid into descending colon where Aft-balloon is distended to fix the overtube inside the colonic segment. Then DiLumen® is pulled back to straighten and to shorten the colon. The colonoscope is advanced forward till transverse colon is reached. The Aft balloon is collapsed and DiLumen® is advanced into transverse colon over the colonoscope. The Aft balloon is distended inside the transverse colon and DiLumen® is pulled back now shortening and straightening the left colon. This process is repeated till the cecum is reached.

Results

We reviewed use of DiLumen® to facilitate colonoscopy in 53 patients (25 males, 28 females, mean age 68.0±10.1 years). Prior to referral for DiLumen®-assisted procedure, one colonoscopy attempt was unsuccessful in 31 patients, 19 patients had 2 unsuccessful colonoscopies, 2 patients had 3 unsuccessful colonoscopies and 1 patient had 4 unsuccessful colonoscopy attempts. The most common reasons for failure were long, redundant, torturous colons. DiLumen® effectively straightened and shortened the colon markedly facilitating advancement of the colonoscope and allowing successful examination of the entire colon with cecal intubation in all 53 patients (technical success 100%). Mean time to reach cecum was 13.1±6.8 minutes and total procedure time was 30.6±15.2 minutes. Normal colonic mucosa was seen in 13 patients (24.5%). Majority (75.5%) of patients had significant pathology found: only 1 polyp was found in 14 patients (26.4%), 2 polyps were found in 10 patients (18.9%), 3 and more (up to 9) polyps were found in 16 patients (30.2%). The polyps ranged in size from 3 to 80 mm and were found in all colonic segments from rectum to ileocecal valve.

Conclusion

Endoscopic double balloon interventional platform markedly facilitated colonic straightening and shortening and allowed successful completion of colonoscopy with removal of previously undetected colonic polyps in patients with difficult (long, redundant and torturous) colon and unsuccessful previous colonoscopies.

References

1. Witte TN, Enns R. The difficult colonoscopy. 2007 Aug; 21(8): 487–490.
2. Baxter NN, Goldwasser MA, Paszat L, Saskin R, Urbach DR, Rabeneck L. A population-based case control study of the effectiveness of colonoscopy for prevention of death from CRC. Gastroenterology. 2007;132:A–88.
3. Shah H, Paszat LF, Saskin R, Stukel TA, Rabeneck L. Factors associated with incomplete colonoscopy: A population-based study. Gastroenterology. 2007;132:2297–303.

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.

Introduction

Endoscopic submucosal dissection (ESD) is gaining popularity around the word. However, ESD remains a technically difficult, labor-intensive and time-consuming procedure.

Aims & Methods

Study aim: To describe first clinical experience with recently developed new endoscopic platform to facilitate ESD.
Methods: C¹ endoscopic platform (Lumendi LLC, Westport, CT, USA) is a flexible overtube with a balloon on its distal end and attached instrument channel. The C¹ was preloaded on top of any colonoscope and inserted into colon till pre-cancerous or early cancerous lesion is reached. After circumferential incision around the lesion was completed with a commercially available ESD knife, a specially designed flexible grasper (Lumendi LLC, Westport CT, USA) was advanced through the instrument channel. The separated edge of the lesion was grasped with the grasper to facilitate ESD. After completion of the ESD, C¹ was used a conduit to deliver Overstitch endoscopic suturing device mounted on a double channel upper endoscope (GiF 2T180, Olympus, Center Valley, PA, USA) to the site of lesion removal to perform sutured closure of the post-ESD defect.

Results

C¹ platform was used in 7 patients (3 females, 4 males, age 62.1±10.1 years) with large (35.0±13.5 mm) sessile colonic polyps. Most lesions were located in anatomically difficult positions (splenic and hepatic flexure, appendix and ileocecal valve). On-demand inflation of the C¹ balloon facilitated advancement of the colonoscope through the colon and shortening and straightening of the colonic turns. None of the patients required external pressure or a change of patient position and in all cases the colonoscope was successfully advanced to the cecum. When the lesion was reached, the balloon was distended providing stabilization of the colonoscope during ESD. Flexible grasper provided multidirectional dynamic retraction of the lesion making endoscopic dissection simple and fast (total ESD time 38.7±16.5 minutes with mean dissection speed 24.8 mm²/minute). After completion of dissection, the lesion was retrieved through C¹ and then Overstitch suturing device was easily delivered to the ESD site. Suturing closure of post-ESD defects was successfully achieved in all patients. There were no device related adverse events during the study.

Conclusion

Newly developed C¹ endoscopic platform with a flexible grasper significantly facilitates colonic ESD.

Introduction

Colonoscopy is not a difficult procedure for most of the colonoscopists. However, some procedures can be challenging even for highly-skilled 4th-level colonoscopists (Kudo’s classification). Magnetic balloon technology was developed to facilitate loop solving and colonoscopy completion.

Aims & Methods

Patients with prior incomplete sedated colonoscopy performed by the author were selected if tortuosity, redundancy or laxity were reported in prior failed colonoscopy. For each patient a colonoscopy with magnetic balloon was rescheduled and performed in the same center (Ospedale San Giuseppe, Empoli, Firenze, Italy) by the same endoscopist (4 th level expert according to Kudo’s classification with completion rate higher than 98%). Complete colonoscope insertion was judged by the colonoscopist if ileocecal valve and the appendiceal orifice could be observed. Magnetic balloon technology includes a balloon catheter that can be inserted on demand in the 3,2 mm colonoscope tool channel, filled with a syringe of ferromagnetic fluid and anchored with an external permanent magnet. The magnetic anchorage is performed to facilitate manoeuvres to solve loops and thus straightening and shortening the colonoscope.

Results

From February to March 2022 a colonoscopy with magnetic balloon and conscious sedation with midazolam and fentanyl were performed in four Caucasian patients (50-74 yrs, 3 males, BMI: 24,6- 37,1). All patients completed the colonoscopy with magnetic balloon. Tortuosity, laxity and/or redundancy were identified in all cases. Magnetic balloon anchorage has been always achieved even in an obese male patient (BMI 37,1). No adverse events occurred.

Conclusion

Magnetic balloon technology may represent a new safe and effective on demand solution forcompleting very difficult colonoscopies and preventing rescheduling of a second procedure.

References

Gan T, Yang JL, Wu JC, Wang YP, Yang L. When and why a colonoscopist should discontinue colonoscopy by himself? World J Gastroenterol. 2015 Jul 7;21(25):7834-41. doi: 10.3748/wjg.v21.i25.7834. PMID: 26167083; PMCID: PMC4491970.
Kudo S. Colonoscopy insertion techniques. 1st ed. Tokyo: The Medical Book Pub, 1997: 18-79

Disclosure

no disclosures

Introduction

Currently, colorectal cancer is the second leading cause of death worldwide¹. Therefore, colon cancer screening tests such as colonoscopy and fecal occult blood test (FOBT) are performed to reduce the mortality and incidence of colorectal cancer^2-5. Although FOBT is a simple test, positive patients eventually require colonoscopy to confirm the presence of lesions. Thus, colonoscopy is gold standard to detect and diagnose colon cancer. However, performing a colonoscopy requires a high level of skill in colon insertion, making it challenging for beginner colonoscopists to achieve total colonoscopy. Furthermore, cases involving longer colons and adhesions require even more advanced techniques. Therefore, a new colonoscope that allows safe and easy colon insertion is desired.

Aims & Methods

To simplify colon insertion, a prototype of robotic colonoscope was developed using 3D printer. The device consists of an outer and an inner tube with a balloon and a bending function. Therefore, the mechanism is characterized by the tip of the inner tube being pushed out to the off-axis by tip direction of outer tube. The insertion method is expected to avoid excessive stretching of the intestinal tract. They are independently and electrically manipulated to bend and push/pull using servo motor via a controller, so it has potential to insert total colon alone.
The model was designed with a maximum outer diameter of 14 mm. Therefore, it can insertion test using colon model. In this study, insertion to colon model of case 1 (Colonoscope training model, KYOTO KAGAKU Co., LTD, Japan) was investigated using the developed device.

Results

Investigation of the operation of the developed device confirms that the controller can be used to control bending of the outer and inner tubes, inflation and deflation of balloons attached to the outer and inner tubes, and pushing and pulling of the inner tube. The maximum angles of the outer and inner tubes were approximately 90 and 180 degrees, respectively. The balloons were confirmed to inflate to a diameter of approximately 7 cm, which is sufficient for intestinal fixation. In addition, the tips of the outer and inner tubes could lift up to 200 and 50 g, respectively.
In the insertion test, the device was reached from the anus to the cecum in approximately 440 s by a non-medical operator alone. In addition, the device can be inserted into the colon model without excessive stretching during the test.

Conclusion

In this study, a prototype of robotic colonoscope with double-balloon and double-bend tube was developed to simplify insertion, and it was confirmed well operated properly. In insertion test, the device could be reached to cecum of colon model (Case 1) by non-medical operator alone. In addition, the behavior was free from over-extended colon model, thus, it suggests that the mechanism of prototype can contribute to comfortable colonoscopy.

References

1. Sung, H. et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians 71, 209-249, (2021).
2. Chiu, H. M. et al. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer 121, 3221-3229, (2015).
3. Zorzi, M. et al. Impact on colorectal cancer mortality of screening programmes based on the faecal immunochemical test. Gut 64, 784, doi:10.1136/gutjnl-2014-307508 (2015).
4. Nishihara, R. et al. Long-Term Colorectal-Cancer Incidence and Mortality after Lower Endoscopy. New England Journal of Medicine 369, 1095-1105, (2013).
5. Doubeni, C. A. et al. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut 67, 291, (2018).