PROSPECTIVE, RANDOMIZED CONTROLLED STUDY EVALUATING DOUBLE BALLOON INTERVENTIONAL ENDOSCOPIC PLATFORM FOR COLORECTAL ESD.

BACKGROUNDS & AIMS: Endoscopic submucosal dissection (ESD) can be challenging/time-consuming. A Double Balloon Interventional Platform (DBIP) was designed to assist with navigation, stabilization, traction and device delivery during complex colorectal polypectomy. STUDY AIM: to compare traditional (T-ESD) to DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial. METHODS: Patients with colorectal polyps ≥ 2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. Primary study endpoint: mean total procedure time difference between groups. Secondary endpoints: intra-procedural time-points, en bloc resection rate, procedure cost, adverse events, and 3-month assessment. A sample size of 200 subjects for ≥ 80% power was calculated. Interim analysis for early study termination was planned at 70% enrolment if primary endpoint was met (p ≤ 0.05). RESULTS: 147 patients were enrolled between February 2019-February 2020. Seven patients dropped out. Interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, co-morbidities, lesion size/location/classification were similar between groups. Mean procedure time decreased with DBIP (88.6±42.7 min) vs. T-ESD (139.5±83.2 min), [51 minutes, 36.5%, p<0.001], with procedural savings of $760.16 (14%) per patient after DBIP cost. DBIP increased dissection speed by 49.0% (15.1±8.0 vs 7.7±6.6 cm2/hour, p< 0.001). En bloc resection was superior with DBIP (97.2% vs 87.0%, p=0.030). Mean navigation time with DBIP for sutured defect closure decreased by 7.7 minutes (p<0.001). There were no adverse events in the DBIP group. CONCLUSIONS: DBIP decreased total procedure time, improved en bloc resection rate, facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption.

Conventional Versus Traction Endoscopic Submucosal Dissection for Colorectal Tumors: A Meta-analysis of Randomized Controlled Trials.

INTRODUCTION: Compared with conventional endoscopic submucosal dissection (C-ESD) for colorectal lesions, the traction method (T-ESD) allows the lesion to be stabilized with easier dissection. However, randomized controlled trials (RCTs) have reported conflicting results on the clinical outcomes of T-ESD as compared with C-ESD. We conducted a meta-analysis to compile the data. METHODS: Multiple databases were searched for RCTs evaluating C-ESD versus T-ESD for colorectal tumors. The end points of interest were procedure time (min), resection speed (mm²/min), R0 resection, en bloc resection, delayed bleeding, and perforation. Standard meta-analysis methods were employed using the random-effects model. RESULTS: Six RCTs with a total of 566 patients (C-ESD n=284, T-ESD n=282) were included. The mean age was 67±10 y and 60% were men. As compared with the T-ESD technique, the C-ESD group was associated with longer procedure time (SMD 0.91, 95% CI 0.58 to 1.23, P<0.00001) and lesser resection speed (SMD -1.03, 95% CI -2.01 to -0.06, P=0.04). No significant difference was found in the 2 groups with respect to R0 resection rate (RR 1.00, 95% CI 0.94 to 1.06, P=0.87), en bloc resection (RR 0.99, 95% CI 0.97 to 1.01, P=0.35), delayed bleeding (RR 0.66, 95% CI 0.17 to 2.59, P=0.55) and perforation (RR 2.16, 95% CI 0.75 to 6.27, P=0.16). DISCUSSION: On meta-analysis, pooled procedure time was significantly faster with T-ESD compared with C-ESD. The clinical outcomes, however, were comparable.

Purely endoscopic appendectomy.

Video 1Submucosal nodule in the cecum. After submucosal injection, a circumferential incision of the mucosa surrounding the lesion is performed with DualKnife (Olympus America, Center Valley, Pa, USA). The fore-balloon of the double-balloon endoluminal interventional platform (DBEIP) is deployed and the edges of the circumferential incision are attached with 2 endoscopic clips to the long suture-loop mounted on the fore-balloon of the DBEIP. The fore-balloon is retracted in anal direction, pulling the lesion into the cecum. Careful endoscopic submucosal dissection is performed with DualKnife and HookKnife (Olympus America). Dissection is markedly facilitated by traction and continued until the entire appendix is pulled into the cecum. The tip of the appendix is separated from surrounding tissues, resulting in a full-thickness cecal wall defect. The suture-loop holding the resected appendix is cut with LoopCutter (Olympus America). The resected appendix is removed through DBEIP and the Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, Tex, USA) is advanced into the cecum. The full-thickness defect in the cecal wall is completely closed with 2 continuous sutures. The final view demonstrates the entire resected appendix.

The Development of the Overstitch System and Its Potentials.

Endoscopic suturing device for flexible endoscopy was conceptualized by Apollo Group in collaboration with Olympus Optical Ltd. The first modification of suturing device for flexible endoscopy (Eagle Claw) was manufactured by Olympus engineers and extensively used by members of Apollo Group in numerous bench-top experiments on isolated pig stomachs and in live porcine model. The suturing system for flexible endoscopy in humans (Overstitch) was cleared for general clinical use in the United States in 2008. The latest model is compatible with more than 20 single-channel flexible endoscopes with diameters ranging from 8.8 mm to 9.8 mm made by major endoscope manufacturers.

Esophageal capsule endoscopy is not the optimal technique to determine the need for primary prophylaxis in patients with cirrhosis.

INTRODUCTION: Capsule endoscopy has been suggested as a potential alternative to endoscopy for detection of esophagogastric varices and severe portal hypertensive gastropathy (PHG). The aim of the study was to determine whether PillCam esophageal capsule endoscopy could replace endoscopy for screening purposes. MATERIAL AND METHODS: Sixty-two patients with cirrhosis with no previous variceal bleeding had PillCam capsule endoscopy and video endoscopy performed on the same day. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of capsule endoscopy were compared to endoscopy for the presence and severity of esophageal and gastric varices, PHG and the need for primary prophylaxis. Patients' preference was assessed by a questionnaire. RESULTS: Four (6%) patients were unable to swallow the capsule. Sensitivity, specificity, PPV and NPV of capsule endoscopy for detecting any esophageal varices (92%, 50%, 92%, 50%), large varices (55%, 91%, 75%, 80%), variceal red signs (58%, 87%, 69%, 80%), PHG (95%, 50%, 95%, 50%), and the need for primary prophylaxis (91%, 57%, 78%, 80%) were not optimal, with only moderate agreement (κ) between capsule and upper GI endoscopy. Had only a capsule endoscopy been performed, 12 (21.4%) patients would have received inappropriate treatment. Capsule endoscopy also failed to detect (0/13) gastric varices. The majority of patients ranked capsule endoscopy as more convenient (69%) and their preferred (61%) method. CONCLUSIONS: Despite the preference expressed by patients for capsule endoscopy, we believe that upper GI endoscopy should remain the preferred screening method for primary prophylaxis.

Endoscopic Suturing, an Essential Enabling Technology for New NOTES Interventions.

Natural orifice transluminal endoscopic surgery (NOTES) was developed as a new, minimally invasive approach for various interventions inside the peritoneal cavity. Since the first reports of NOTES animal interventions, various devices have been used for closure of the transluminal entrance site. This article reviews the most commonly used endoscopic closure devices and advantages of the latest generation of endoscopic suturing devices enabling reliable, surgical-quality closure of the full-thickness gastrointestinal wall defects.

Endoscopic management of colonic perforations: clips versus suturing closure (with videos).

BACKGROUND AND AIMS: Perforation during colonoscopy remains the most worrisome adverse event and usually requires urgent surgical rescue. The aim of this study was to evaluate the feasibility and effectiveness of endoscopic closure of full-thickness colonic perforations. METHODS: We performed a retrospective analysis of all consecutive patients with endoscopically closed colonic perforations over the past 6 years (2009-2014). Colonic perforations were closed by using endoscopic clips or an endoscopic suturing device. Most patients were admitted for treatment with intravenous antibiotics and kept on bowel rest. If their clinical condition deteriorated, urgent surgery was performed. If patients remained stable, oral feeding was resumed, and patients were discharged with subsequent clinical and endoscopic follow-up. RESULTS: Twenty-one patients had iatrogenic colonic perforations closed with an endoscopic suturing device or endoscopic clips during the study period. Primary closure of a colonic perforation was performed with endoscopic clips in 5 patients and sutured with an endoscopic suturing device in 16 patients. All 5 patients after clip closure had worsening of abdominal pain and required laparoscopy (4 patients) or rescue colonoscopy with endoscopic suturing closure (1 patient). Two patients had abdominal pain after endoscopic suturing closure, but diagnostic laparoscopy confirmed complete and adequate endoscopic closure of the perforations. The other 15 patients did not require any rescue surgery or laparoscopy after endoscopic suturing. The main limitation of our study is its retrospective, single-center design and relatively small number of patients. CONCLUSION: Endoscopic suturing closure of colonic perforations is technically feasible, eliminates the need for rescue surgery, and appears more effective than closure with hemostatic endoscopic clips.

New endoscopic platform for endoluminal en bloc tissue resection in the gastrointestinal tract (with videos).

BACKGROUND: Endoscopic removal of gastrointestinal tract lesions is increasingly popular around the world. We evaluated feasibility, safety, effectiveness, and user learning curve of new endoscopic platform for complex intraluminal interventions. METHODS: A novel system, consisting of expandable working chamber with two independent instrument guides (LIG), was inserted into colon. Simulated colonic lesions were removed with endoscopic submucosal (ESD) and submuscular (ESmD) dissection. RESULTS: In all nine in vivo models, an intraluminal chamber and its dynamic tissue retractors (via LIG) provided a stable working space with excellent visualization and adequate access to target tissue. Endoscopic platform facilitated successful completion of 11 en bloc ESDs (mean size 43.0 ± 11.3 mm, mean time 46.3 ± 41.2 min) and eight ESmD (mean size 50.0 ± 14.1 mm, mean time 48.0 ± 21.2 min). The learning curve for ESD using this platform demonstrated three phases: rapid improvement in procedural skills took place during the first three procedures (mean ESD time 98.7 ± 40.0 min). A plateau phase then occurred (procedures 4-7) with mean procedure time 42.0 ± 13.4 min (p = 0.04), followed by another sharp improvement in procedural skills (procedures 8-11) requiring only 16.3 ± 11.4 min (p = 0.03) to complete ESD. Especially dramatic (p = 0.002) was the time difference between the first three procedures (mean time 98.7 ± 40.0 min) and subsequent eight procedures (mean time 29.1 ± 17.9 min). CONCLUSIONS: A newly developed endoscopic platform provides stable intraluminal working space, dynamic tissue retraction, and instrument triangulation, improving visualization and access to the target tissue for safer and more effective en bloc endoscopic submucosal and submuscular dissection. The learning curve for ESD was markedly facilitated by this new endoscopic platform.

Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos).

BACKGROUND: Endoscopic submucosal dissection (ESD) is less invasive than surgical resection, but the large mucosal defects after ESD may lead to adverse events necessitating hospitalizations. OBJECTIVE: To evaluate the use of an endoscopic suturing device for closure of large mucosal defects after ESD. DESIGN AND SETTING: Retrospective, single-center study. PATIENTS: Twelve consecutive patients underwent ESD. INTERVENTIONS: All lesions were removed by using a previously described ESD technique. The large mucosal defects post-ESD were completely closed with the endoscopic suturing device, and all patients were discharged home with subsequent clinical and endoscopic follow-up. MAIN OUTCOME MEASUREMENTS: Bleeding and perforation rates after ESD with mucosal defect closure. RESULTS: ESD followed by endoscopic suturing of the mucosal defects was performed in 12 patients (mean age, 64.7 ± 11.2 years, 4 lesions in the stomach, 8 lesions in the colon; mean lesion size, 42.5 ± 14.8 mm) over a period of 8 months. All lesions (100%) were removed en bloc. Closure of post-ESD defects with an endoscopic suturing device was technically feasible and fast (mean closure time, 10.0 ± 5.8 minutes per patient). Only 1 stitch (continuous suturing line) was required for complete closure in 8 patients. In the other 4 patients, the mucosal defect was closed with 2 to 4 separate stitches (mean number of sutures per patient, 1.6 ± 1.0). There were no immediate or delayed adverse events in any of the study patients. LIMITATIONS: Retrospective study. CONCLUSIONS: Closure of large post-ESD defects with the Overstitch endoscopic suturing device is technically feasible and fast and can significantly decrease treatment cost by eliminating the need for hospitalization.

Nonsurgical treatment of actively bleeding internal hemorrhoids with a novel endoscopic device (with video).

BACKGROUND: Internal hemorrhoids often present with bleeding, prolapse, and other symptoms. Currently used nonsurgical treatment modalities have limited effectiveness and usually require several treatment sessions. OBJECTIVE: To evaluate effectiveness and safety of a novel endoscopic device for nonsurgical treatment of internal hemorrhoids. DESIGN: Retrospective study. SETTING: Single center. PATIENTS: This study involved 23 patients with actively bleeding internal hemorrhoids. INTERVENTION: The HET Bipolar System is a modified anoscope, with a treatment window, light source, and tissue temperature monitor. The device is inserted into the rectum under direct observation. The tissue carrying superior hemorrhoidal branches and the apex of the internal hemorrhoid is positioned inside the treatment window, clamped with incorporated tissue forceps, and treated with bipolar energy to ligate hemorrhoidal feeding vessels. MAIN OUTCOME MEASUREMENTS: Rate of hemorrhoidal bleeding after the treatment. RESULTS: The mean age of the patients was 64.3 ± 9.9 years (range 44-79 years). Eleven patients (47.8%) had grade I hemorrhoids and 12 patients (52.2%) had grade II hemorrhoids. In 18 patients (78.3%), treatment with the HET System was performed with the patient under conscious sedation. Five patients (21.7%) were treated without sedation. All patients tolerated treatment without complaints. The average follow-up period was 11.2 ± 4.7 months. No bleeding or prolapse occurred after the procedure in any of the treated patients. LIMITATIONS: Retrospective study. CONCLUSION: The newly developed HET System is easy to use, safe, and highly effective in eliminating bleeding in grade I and II internal hemorrhoids and prolapse in grade II internal hemorrhoids.