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.

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.

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.

Interventional EUS.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of new or emerging endoscopic technologies that have the potential to have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent preclinical and clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but, in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. For this review, the MEDLINE database was searched through August 2009 by using the keywords "interventional endoscopic ultrasound," "EUS," and "interventional endoscopy." Reports on Emerging Technologies are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. These reports are scientific reviews provided solely for educational and informational purposes. Reports on Emerging Technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Infection during natural orifice transluminal endoscopic surgery: a randomized, controlled study in a live porcine model.

BACKGROUND: Currently reported natural orifice transluminal endoscopic surgery (NOTES) procedures in animals have been done in heterogeneous milieus ranging from nonsterile to sterile procedures, with mixed results, including no infection in those performed in nonsterile settings. OBJECTIVE: To establish the potential frequency of infection during NOTES, comparing sterile to nonsterile approaches. SETTING: Survival experiments on sixteen 50-kg pigs. DESIGN AND INTERVENTIONS: From pilot data (100% infection frequency after nonsterile procedures), sample size (8 animals in each group) was calculated by using a power of 95% and an alpha risk of 0.05. The animals were randomly assigned to two groups: In the transgastric peritoneoscopy study group, liver and ovarian biopsies were performed with sterile overtubes, endoscopes, and accessories and the use of preoperative intravenous antibiotics and antiseptic gastric lavage. In the nonsterile (control) group, the same procedures were performed with nonsterile endoscopes and accessories without the use of gastric lavage and preoperative antibiotics. Complete transmural closure of the transgastric access site was made in all animals. After a 1-week survival time, all animals were killed for necropsy, which included Gram staining and peritoneal cultures. MAIN OUTCOME MEASUREMENTS: Intraperitoneal infection on necropsy. RESULTS: All necropsies revealed intraperitoneal infection (abscesses, fibrinopurulent exudates, and adhesions) in the control group (frequency of infection 100%). Peritoneal bacterial culture grew various aerobic and anaerobic organisms. No gross or bacteriological evidence of infection was seen in the sterile group (frequency of infection 0%, P value = <.0002). LIMITATIONS: Animal experiments. CONCLUSION: Nonsterile conditions invariably lead to intraperitoneal infection. Aseptic techniques during NOTES can prevent intra-abdominal infection. Future studies will determine which infection prevention steps are mandatory and which can be omitted during NOTES procedures.

Gastric wall healing after NOTES procedures: closure with endoscopic clips provides superior histological outcome compared with threaded tags closure.

BACKGROUND: Closure of the transgastric access to the peritoneal cavity is a critical step in natural orifice transluminal endoscopic surgery (NOTES). OBJECTIVE: To perform a direct comparison of the histological healing post clips and threaded tags (T-tags) closure after transgastric NOTES procedures. DESIGN AND INTERVENTION: Twelve survival porcine experiments. After standardized endoscopic gastric wall puncture, balloon-dilation, and transgastric peritoneoscopy, closure of the gastric wall was performed with either clips or T-tags. Necropsy at 14 days was performed for histological evaluation of 2-mm interval transversal cross sections of the gastrotomy site. MAIN OUTCOME MEASUREMENTS: Histological healing of the gastric wall opening. RESULTS: Endoscopic closure of the gastrotomy was successfully achieved in all 12 animals, followed by an uneventful 2-week clinical follow-up. Transmural healing was seen in 3 (75%) animals after clip closure compared with only 1 (12.5%) in the group with T-tag closure (P = .06). Gastric wall muscular bridging was observed in 4 (100%) animals with clip closure compared with only 1 (12.5%) in the group with T-tag closure (P = .01). LIMITATIONS: Animal model with short-term follow-up. CONCLUSIONS: Endoscopic clip closure results in a layer-to-layer transmural healing of the gastric wall. In contrast, T-tag gastric wall plication impairs gastric layer bridging. These findings might guide the future design of new endoscopic devices and techniques for gastrotomy closure after NOTES procedures.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

A 2-microm continuous-wave laser system for safe and high-precision dissection during NOTES procedures.

INTRODUCTION: Lasers 2-microm in wavelength offer efficient tissue cutting with limited thermal damage in biological tissue. OBJECTIVE: To evaluate the dissection capabilities of a 2-microm continuous-wave laser for NOTES procedures. METHODS AND PROCEDURES: We conducted 18 acute animal experiments. Group 1 (three animals): transcolonic access to the peritoneal cavity (15-W transcolonic laser puncture, balloon dilation over the laser probe). Group 2 (six animals): transcolonic access with needle-knife puncture and balloon dilation. Group 3 (three animals): transgastric access to the peritoneal cavity (similar technique as group 1) followed by laser-assisted dissection of the kidney. In one animal of group 3, a therapeutic target (hematoma) was created by percutaneous puncture of the kidney. Group 4 (six animals): transgastric access (similar to the technique of group 2). RESULTS: Translumenal access to the peritoneal cavity was achieved in 2-3 min in group 1 (significantly shorter than with the needle-knife-assisted technique, 4-5 min, p=0.02) and in 7-10 min in group 3 (compared to 6-17 min in group 4, p=0.88). In group 3, laser dissection of the parietal peritoneum and of perinephric connective tissue allowed access to the retroperitoneum with complete removal of a blood collection in the animal with puncture trauma. Laser dissection demonstrated good maneuverability, clean and rapid cutting, and excellent hemostasis. Peritoneoscopy and necropsy showed no damage of targeted tissue and surrounding organs. CONCLUSIONS: The 2-microm continuous-wave laser system showed promising capabilities for highly precise and safe dissection during NOTES procedures.

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.

Patient- and cyst-related factors for improved prediction of malignancy within cystic lesions of the pancreas.

BACKGROUND AND AIMS: Early diagnosis of cancer in pancreatic cysts is important for timely referral to surgery. The aim of this study was to develop a predictive model for pancreatic cyst malignancy to improve patient selection for surgical resection. METHODS: We performed retrospective analyses of endoscopic ultrasound (EUS) and pathology databases identifying pancreatic cysts with available final pathological diagnoses. Main-duct intraductal papillary mucinous neoplasms (IPMNs) were excluded due to the clear indication for surgery. Patient demographics and symptoms, cyst morphology, and cyst fluid characteristics were studied as candidate risk factors for malignancy. RESULTS: 270 patients with pancreatic cysts were identified and analyzed (41% men, mean age 61.8 years). Final pathological diagnoses were branch-duct IPMN (n = 118, 50% malignant), serous cystadenoma (n = 71), pseudocyst (n = 37), mucinous cyst adenoma/adenocarcinoma (n = 36), islet cell tumor (n = 4), simple cyst (n = 3), and ductal adenocarcinoma with cystic degeneration (n = 1). Optimal cut-off points for surgical resection were cyst fluid carcinoembryonic antigen (CEA) > or =3,594 ng/ml, age >50, and cyst size >1.5 cm. Cyst malignancy was independently associated with white race (OR = 4.1, p = 0.002), weight loss (OR = 3.9, p = 0.001), cyst size >1.5 cm (OR = 2.4, p = 0.012), and high CEA > or =3,594 (OR = 5.3, p = 0.04). In white patients >50 years old presenting with weight loss and cyst size >1.5 cm, the likelihood of malignancy was nearly sixfold greater than in those patients who had none of these factors (OR = 5.8, 95% CI = 2.1-16.1, p = 0.004). CONCLUSIONS: Risk factors other than cyst size are important for determination of malignancy in pancreatic cysts. Exceptionally high cyst fluid CEA levels and certain patient-related factors may help to better predict cyst malignancy and the need for surgical treatment.