Introduction

Deep intubation of the small bowel can be difficult during double balloon enteroscopy (DBE). A stiffening wire may help by reducing loop formation and improving handling characteristics of the enteroscope. We conducted a single blind randomized controlled trial to determine the effectiveness of a stiffening wire to increase insertion depth.

Aims & Methods

Consecutive patients undergoing DBE between 2016 to 2022 were eligible to participate in the study. All patients had an abnormality on small bowel imaging before the procedure. Patients underwent DBE using standard technique and were excluded if the abnormality was reached since further insertion was not necessary. If the abnormality could not be reached, patients were randomized to either the stiffening wire or control, after which the endoscopist was given three attempts to advance the enteroscope further. The primary outcome was insertion depth after randomization and secondary outcomes included total insertion depth, diagnosis, intervention, pain score, and adverse event. Insertion depth was determined using the fold counting method¹ and scored by a blinded outcome assessor who reviewed recorded videos of the withdrawal phase of each procedure.

Results

A total of 54 subjects were enrolled (median age 68, 46% female, 28 to stiffening wire and 26 to control). The most common indication was small bowel bleeding (57%) and most cases were performed after an abnormal capsule study (83%). Overall, post-randomization insertion depth was significantly greater in the stiffening wire group compared to the control (135 cm vs. 19 cm, p<0.001), as was total insertion depth (502 cm vs. 391 cm, p=0.015). There were no significant differences in the types of diagnoses or interventions performed between the two groups although there was a trend towards fewer procedures having no intervention in the stiffening wire group (42% vs. 26%, p=0.25). There were no significant differences in pain scores but there were two adverse events in the intervention group, neither of which were related to the stiffening wire.

Conclusion

A stiffening wire is a simple and useful tool to increase the depth of insertion during DBE.

References

1. Efthymiou M, Desmond PV, Brown G, et al. SINGLE-01: a randomized, controlled trial comparing the efficacy and depth of insertion of single- and double-balloon enteroscopy by using a novel method to determine insertion depth. Gastrointest Endosc 2012;76:972-80.

Disclosure

Dr. Michael Sey: Medtronic (consultant), Pendopharm (research grants, speaker) and Cook Medical (educational grant).

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

Pain, discomfort, and bloating can occur during and after colonoscopy, secondary to bowel distention. Insufflation is the major reason for bowel distention after a colonoscopy. Room air (RA) has slower re-absorption through the intestinal mucosa than carbon dioxide (CO2). Theoretically, with a faster resorption speed, abdominal pain, discomfort, and bloating are expected to be less with CO2 use. Nevertheless, in some clinical studies, CO2 was not found to be superior to RA in terms of post-procedure pain sensation.

Aims & Methods

The aim of this study was to compare abdominal pain sensation and bloating after colonoscopy using RA versus CO2 insufflation. A prospective randomized controlled study conducted on patients performing diagnostic colonoscopy. Enrolled patients were randomized to RA (group 1) versus CO2 insufflation (group 2). All patients were sedated with midazolam (2.5-5 mg) and all colonoscopies were performed by a single endoscopist. Abdominal pain sensation and bloating after the procedure as the primary outcome measure was assessed by a 10-point visual analogue scale (VAS), numerical rating scales from 0 (no pain) to 10 points (maximal pain). The participants were asked about abdominal pain and bloating at 15, 60, and 180 minutes and 24 hours post-procedural.

Results

From July 2021 to August 2022, a total of 64 patients were enrolled. There was 31 males and 33 females. Their mean age was 48.27±16 years. There was a statistically significant increase in abdominal bloating in group 1 (59.4%) compared to group 2 (18.7%), (P=0.018). Also, there was a statistically significant increase in abdominal pain sensation in group 1 compared to group 2 at 60 min (43.8% vs 21.9%) (P=0.011), 180 min (28.1% vs 9.4%) (P=0.017), respectively. None of the studied patients developed pain after 24 hours and there was no statistically significant difference between the studied groups regarding cecal intubation time and total examination time. No adverse events were noted in both groups.

Conclusion

CO2 insufflation is associated with significantly less bloating and less abdominal pain after diagnostic colonoscopy compared to RA insufflation.

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

Lower gastrointestinal bleeding (LGIB) is usually self-limited, although serious bleeding requiring blood transfusion, surgery, and death can occur in a minority of individuals. Risk scores can differentiate between these patients and identify who can be safely discharged from the emergency department (ED), although which score should be used is unknown.

Aims & Methods

We conducted a prospective cohort study at 8 hospitals across Canada of patients presenting with hematochezia to the ED. Individuals 18 years or older were eligible regardless if they were admitted or discharged from the ED. LGIB risk scores, informed by a prior systematic review and meta-analysis¹, were calculated at presentation for the Oakland, Strate, and BLEED scores. Two commonly used upper gastrointestinal bleeding risk scores were also included: the Glasgow-Blatchford score (GBS) and the clinical Rockall score (cRockall). All subjects were followed for 28 days. The primary outcome was safe discharge, defined as the absence of rebleeding, readmission, need for blood transfusion, endoscopic hemostasis, radiologic hemostasis, surgery, and death at 28 days. The performance of each score was evaluated for its overall discriminative ability (c-statistic) in predicting safe discharge. Calibrations were assessed using calibration belt plots as well as grouped calibration plots. The c-statistics of LGIB and UGIB risk scores were separately compared and adjusted for multiplicity with a focus on comparison to the Oakland score. Sensitivities and specificities were determined for each score.

Results

Between Sep 2019 and Feb 2024, a total of 529 subjects were screened, of whom 344 were enrolled. The mean (SD) age was 59.5 years (19.6), 48.5% were female, and 27.4% had a Charlson Comorbidity Index score ≥3. Overall, 39.7% of patients were admitted to hospital. At 28 days follow-up, 4.6% were readmitted, 10.7% needed blood transfusions, 6.2% had endoscopic hemostasis, 0.3% had radiological hemostasis, 3.3% had surgery, and 1.3% died. Overall, 79.3% had a composite endpoint of safe discharge within 28 days. Among LGIB risk scores, the AUC (95% CI) was 0.71 (0.63-0.78) for the Oakland score, 0.67 (95% CI 0.57-0.75) for the Strate score, and 0.61 (95% CI 0.53-0.68) for the BLEED score. For UGIB risk scores, the AUC (95% CI) was 0.76 (0.67-0.84) for the GBS and 0.62 (0.54-0.70) for the cRockall score. The sensitivity and specificity for each score were as follows: 23.1% and 92.1% for the Oakland score; 16.7% and 91.7% for the Strate score; 47.4% and 77.8% for the BLEED score; 50% and 88.1% for the GBS; 25.8% and 88.8% for the cRockall, respectively.

Conclusion

The Oakland score can predict safe discharge with a high degree of specificity, but clinical judgment should still be used. If a single risk score for both UGIB and LGIB is desired, then the GBS may be a good alternative although further validation is required.

References

1. Almaghrabi M, Gandhi M, Guizzetti L, Iansavichene A, Yan B, Wilson A, Oakland K, Jairath V, Sey M. Comparison of Risk Scores for Lower Gastrointestinal Bleeding: A Systematic Review and Meta-analysis. JAMA Netw Open 2022;5:e2214253.

Disclosure

HS has been on advisory boards or consulted to Pendopharm, Amgen Canada, Abbvie Canada, Innomar, Sandoz Canada, Takeda Canada, and Guardant Health, Inc. None of this is related to the current work. All other co-authors have no relevant disclosures related to this study.