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Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study

Shahid, Haroon M; Bareket, Romy; Tyberg, Amy; Sarkar, Avik; Simon, Alexa; Gurram, Krishna; Gress, Frank G; Bhenswala, Prashant; Chalikonda, Divya; Loren, David E; Kowalski, Thomas E; Kumar, Anand; Vareedayah, Ashley A; Abhyankar, Priya R; Parker, Kasey; Gabr, Moamen M; Nieto, Jose; De Latour, Rabia; Zolotarevsky, Mitchelle; Barber, Jeremy; Zolotarevsky, Eugene; Vazquez-Sequeiros, Enrique; Gaidhane, Monica; Andalib, Iman; Kahaleh, Michel
INTRODUCTION/BACKGROUND:Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS:We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS:A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS:The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.
PMID: 35997700
ISSN: 1539-2031
CID: 5338192

Endoscopy-guided transesophageal echocardiography for large esophageal varices: Use of the "Double Barrel" technique [Case Report]

Rhee, David W; Nayar, Ambika C; Yan, Joe L; Gausman, Valerie; Park, David S; Vareedayah, Ashley A
Rhythm control strategies in patients with esophageal varices and atrial arrhythmias pose a unique challenge. The left atrium should be imaged for a thrombus prior to attempting cardioversion or ablation, but the presence of varices is a relative contraindication for transesophageal echocardiography. We present a safe, novel technique of evaluating for left atrial thrombus with simultaneous transesophageal echocardiography and esophagogastroduodenoscopy using slim probes in a patient with large, high-risk esophageal varices, and symptomatic atrial flutter with rapid ventricular rates despite medical therapy.
PMID: 34713478
ISSN: 1540-8175
CID: 5042812

Outcomes of hybrid technique using endoscopic mucosal resection and endoscopic full-thickness resection for polyps not amenable to standard techniques (with video)

Mahadev, SriHari; Vareedayah, Ashley A; Yuen, Sofia; Yuen, William; Koller, Kristen A; Haber, Gregory B
BACKGROUND AND AIMS/OBJECTIVE:The full-thickness resection device (FTRD) offers a safe and effective approach for resection of complex colorectal lesions, but is limited to lesions under 2 cm in size. A hybrid approach-combining endoscopic mucosal resection (EMR) with FTRD-significantly expands the pool of lesions amenable to this technique; however, its safety and efficacy has not been well established. METHODS:We report a single-center retrospective study of consecutive patients who underwent full-thickness resection of colorectal lesions, either via standalone FTRD or hybrid (EMR+FTRD) approaches. Outcomes of technical success, clinical success (macroscopically complete resection), R0 resection, and adverse events were evaluated. RESULTS:Sixty-nine FTR procedures (38 stand-alone FTR and 31 hybrid EMR + FTR) were performed on 65 patients. The most common indications were nonlifting polyp (43%), or suspected high-grade dysplasia or carcinoma (38%). Hybrid EMR + FTR permitted resection of significantly larger lesions (mean 39 mm, range 15-70 mm) compared with stand-alone FTR (mean 17 mm, range 7-25 mm, p<0.01). Clinical success (91%), technical success (83%), and R0 resection (81%) rates did not differ between standalone and hybrid groups. 96% of patients were discharged home on the day of the procedure. Three adverse events occurred, including 2 patients who developed acute appendicitis. CONCLUSIONS:A hybrid approach combining use of EMR and FTRD maintains safety and efficacy while permitting resection of significantly larger lesions than FTRD alone.
PMID: 33592228
ISSN: 1097-6779
CID: 4786702


Yuen, W; Mahadev, S; Sofia, Yuen P Y; Koller, K; Vareedayah, A A; Haber, G B
The full thickness resection device (FTRD) has become a safe and effective alternative to endoscopic submucosal dissection (ESD) in select cases.One obvious limitation of the FTRD is lesion size, generally less than 20mm.But because polyp size is one of the strongest predictors of advanced histology, many larger lesions may be amenable to a combined approach involving endoscopic mucosal resection (EMR) of the laterally spreading components and full-thickness resection (FTR) of the invasive, non-lifting portion.To our knowledge, a comparison of FTR alone to hybrid EMR + FTR has not been previously published in North America.We report our initial experience using the FTRD alone compared to a hybrid technique combining EMR and FTR in consecutive patients with lesions unresectable by conventional EMR alone. This is a single-center retrospective analysis of prospectively-collected data on consecutive patients who underwent attempted FTR alone or hybrid EMR/FTR.All consecutive patients in whom FTR was attempted during the study were included in this analysis, whether or not FTR was successful.Primary outcomes included technical success, clinical success, R0 resection, and adverse events.Secondary outcomes included procedure duration, adverse events, and subsequent need for surgery.ariataes collected included patient demographics, anticoagulant use, and lesion characteristics. A total of 62 patients underwent either FTR alone (33 patients) or hybrid EMR + FTR(29 patients).The mean lesion size was larger for the hybrid group (36 mm, range 15-60 mm) as compared to FTR alone (19 mm, range 7-40 mm, p<0.01).The FTR procedure was technically successful in 55 of 62 patients (89%).Of these 55 patients, 53 (96%) had R0 resection margins.There was no difference in R0 resection rate among those who underwent hybrid FTR + EMR, (23/24, 96%) versus those who underwent underwent FTR alone (30/31, 97%).In cases of technical failure, R0 resection was not assessed. Two significant adverse events occurred that were directly related to FTR.One patient developed acute appendicitis following FTR of a 15 mm polyp at the appendiceal orifice.One patient suffered an inadvertent perforation.This was immediately identified and successfully closed endoscopically.No bleeding-related adverse events were noted. We demonstrate high rates of technical success, clinical success, R0 resection, and safety.While this is the first study to compare hybrid EMR + FTR to FTR alone from North America, several groups have demonstrated its efficacy and safety elsewhere.In conclusion, our study shows FTR is a safe and effective method to resect large and complex colorectal lesions, and that a hybrid EMR + FTR technique can expand the pool of resectable lesions.Further multi-center prospective studies with the device are needed to assess its long-term safety, efficacy, and curative resection rates. [Formula presented] [Formula presented]
ISSN: 0016-5107
CID: 4470282


Beauvais, J C; O'Donnell, M; Matta, B; Saraceni, M; Bedi, G; Skinner, M J; Tzimas, D; Shah, P C; Serouya, S; Goodman, A J; Janec, E; De, Latour R; Vareedayah, A A; Yuen, W; Sofia, Yuen P Y; Khanna, L; Haber, G B
Background: Lumen-apposing self-expandable metal stents (LAMS) have transformed the management of pancreatic fluid collections over the last two decades. There has since been significant interest in expanding the utility of LAMS for additional therapies such as the management of benign luminal strictures. However, there remains little data on their efficacy and safety when used for this indication. The goal of this study was to define the technical success, clinical success, and complication rates of LAMS when used in the management of benign strictures Methods: This was a retrospective multicenter evaluation of the safety, efficacy, and long-term clinical durability of LAMS in the treatment of benign strictures. The study took place between June 2018 and November 2019. Data collection included demographic information, indication, stent size, use of concurrent balloon dilation including dilation diameter, stent stabilization technique, intra-procedure and post-procedure complications, clinical improvement, and post-procedure follow up outcomes.
Result(s): 30 patients underwent placement of LAMS for a benign luminal stricture, with one having two stents placed during the index procedure at separate areas of stenoses resulting in a total of 31 stents placed. In total, 19 stents were 15 x 10 mm and 12 stents were 20 x 10 mm. No intra-procedural complications were noted. The technical success of deployment was 100%. Clinical resolution of symptoms was present in 25 (83%) patients. Of the patients who experienced clinical improvement, 17 underwent stent removal after an average of 6.4 weeks, and clinical recurrence occurred in 7 (41%) patients. The mean time to recurrence of symptoms after stent removal was 7 weeks. Univariate subgroup analysis revealed 15 x 10 mm stents were associated with clinical improvement (OR 12.86, 95% CI: 1.27-130.57, p 0.031). Each patient who did not clinically improve developed pain (3) or stent migration (2). In total 11 (37%) patients developed minor post-procedure adverse event. Stent migration was seen in 5 (17%) cases. Bleeding and pain were noted in 1 (3%) and 7 (23%) patients, respectively. Ulceration was found in 4 patients.
Conclusion(s): LAMS is a durable, safe option for patients with benign luminal strictures. Overall technical success was 100% and clinical success was 83%. The data also suggests better clinical outcomes with 15 x 10 mm stents, when compared to 20 x 10 mm stents. Pain is the most common adverse event but easily managed. [Formula presented]
ISSN: 1097-6779
CID: 4472152


Beauvais, J C; Yuen, W; Sofia, Yuen P Y; Zaki, T A; Matta, B; Bedi, G; Vareedayah, A A; Haber, G B
Endoscopic mucosal resection (EMR) is standard of care for removal of large laterally spreading colon polyps, but is often complicated by residual neoplastic tissue which is difficult to resect using standard methods.Large prospective studies from tertiary referral centers report 20% recurrence and 13% incomplete resection (A Moss2015). We introduced a new technique to improve resection of visible residual neoplasia (S Andrawes, 2014).Hot avulsion (HA) is a combination of mechanical traction with simultaneous application of short bursts of cutting current to shear adherent tissue, primarily neoplastic remnants which cannot be removed with a snare due to inability to grasp tissue.Use of hot biopsy forceps has been largely discarded due to concern for perforation,serositis,and delayed bleeding.A change in methodology, which emphasizes mechanical traction and cutting current, has altered the application with minimal risk.The advent of this technique has resulted in reduction of incomplete resection of difficult polyps. We performed a retrospective single center review of all consecutive patients undergoing EMR with adjuctive HA over a 3 year period by a single endoscopist to establish a safety profile for HA.Data collection included patient demographics, polyp size and location, intra and post-procedural complications, and time to onset of complications. A total of 134(55%) women and 110(45%) men, mean age 65, were included with 254 unique polyps (using hot avulsion) removed in 244 colonoscopies.10 patients had more than one polyp removed in a session.Average polyp size was 34mm.Polyps were predominantly in the right colon (69%). No clinically significant intra-procedural bleeding was noted.Two intra-procedure perforations were noted and were treated endoscopically.One was directly related to hot avulsion and treated with endoscopic suturing.The other was related to EMR and was closed using hemostatic clips.One patient(0.4%) was found to have a controlled perforation on CT imaging on day 4 post-op resolved with conservative management.It is unclear if this related to EMR or HA.Clinically significant bleeding requiring intervention occurred in six cases (5 treated with clips and 1 with coagulation).Importantly, there was no evidence of post polypectomy syndrome or transmural injury. Perforation definitely related to HA occurred in one patient and was endoscopically recognized and treated.A single delayed perforation of unclear cause was managed conservatively. Post-procedure bleeding required intervention in six patients and felt to be unrelated to the use of HA. Using appropriate parameters for this method, we conclude that hot avulsion is a safe method for adjunctive removal of visible residual neoplasia. [Formula presented] [Formula presented]
ISSN: 1097-6779
CID: 4480382

"the first burn is the deepest:" a cautionary tale in superficial APC therapy for radiation proctopathy [Meeting Abstract]

Pineles, D; Vareedayah, A; Poppers, D
INTRODUCTION: Globally, prostate cancer is the most commonly diagnosed cancer in men. Radiation therapy remains a mainstay in the armamentarium in the treatment of this disease. Radiation proctopathy is a common side effect of this treatment modality with an incidence in patients treated with brachytherapy alone estimated to range from 8 to 13%, and up to 21% in combination with other modalities [2]. Radiation proctopathy typically presents with diarrhea, mucoid discharge, urgency, tenesmus, and bleeding. Argon plasma coagulation (APC) has become the primary therapeutic modality in the management of radiation injury. It is essential that physicians of all specialties (as well as others who care for these patients) be aware of the multiple complications of this therapy. More severe adverse events, notably rectal ulcers following APC therapy are not uncommon, with an incidence ranging from 3 to 16%. CASE DESCRIPTION/METHODS: A 67-year-old man with a history of prostate cancer treated with radiation therapy one year prior presented with intermittent rectal bleeding for one and a half months. A colonoscopy was performed, which revealed a small area near the dentate line characterized by slightly oozing neovascularized tissue consistent with radiation proctopathy. This area was treated with APC with good effect. Biopsies of this area revealed hyperplastic crypts, lamina propria fibrosis, and vascular ectasias compatible with radiation injury. Three months following treatment, the patient developed recurrent rectal bleeding. A flexible sigmoidoscopy revealed a deep nonbleeding ulcer in the rectum. Subsequent CT enterography and MRI of the pelvis demonstrated a deep rectal ulcer with abutment of a 1.5cm peri-prostatic abscess. The patient was followed closely over the next several months in concert with colorectal surgical colleagues, with serial imaging and subsequent resolution of the peri-prostatic abscess as well as cessation of rectal bleeding. DISCUSSION: As more patients with prostate cancer are treated with radiation therapy the incidence of radiation proctopathy is increasing. Although argon plasma coagulation has been shown to be an effective therapy for this issue, providers must consider and discuss with patients the potential complications of this otherwise effective and generally well-tolerated mode of treatment
ISSN: 1572-0241
CID: 4314462


Sofia, Yuen P Y; Vareedayah, A A; Skup, M; Hoerter, N A; Koller, K; Mahadev, S; Haber, G B
EFTR is a safe and effective for resection of colorectal lesions. One limitation to EFTR, however, is lesion size, typically requiring size less than 2cm. For larger lesions, a hybrid technique using EMR followed by EFTR has been described, though this can be associated with risk for perforation with deployment of the clip into the EMR defect.We present our initial experience with hybrid EMR-EFTR in a series of consecutive patients treated in our center, and compare results to EFTR alone.
Study Design: Single-center retrospective cohort study,comparing consecutive pts who underwent EFTR alone(45%)to those who required EMR with EFTR(55%).All procedures were performed by a single, trained endoscopist.Primary outcomes were technical success,R0 resection with respect to vertical margins,and adverse events.Pt demographics,indication,and lesion/procedural characteristics were collected and analyzed.
Method(s): Standard colonoscopy was performed, advancing to the lesion to be resected.In those who underwent EFTR alone, the periphery of the lesion was marked with a cautery probe in four quadrants. The colonoscope was then withdrawn and a second colonoscope with attached cap,clip,snare,and sleeve was reintroduced and advanced to the lesion.Alligator forceps were used to grasp the lesion and retract it within the cap.Full thickness clip was then deployed followed by snare excision of entrapped tissue.For those in the hybrid group with lesions deemed too large for EFTR,we first performed EMR of the periphery to reduce lesion size and allow for EFTR of the central target area.In all cases, tissue was pinned,measured,and sent to pathology.
Result(s): Primary indication for hybrid EMR-EFTR was lesion size.Mean lesion size in the EFTR group was 16mm and 34mm in the hybrid group. Mean procedure time was 67 minutes in EFTR group and 100 minutes in the hybrid group. Histology confirmed R0 resection in 93% in EFTR group and negative vertical margins were found in 78% of lesions in hybrid group. 2 of 4 patients in the hybrid group with positive vertical margins were due to technical failure.In 1 pt the snare was inadvertently closed,with tissue resection prior to clip deployment resulting in a wall defect. A dual grasping forceps was used to pull the margins of the defect into the cap followed by clip deployment with no adverse sequelae. Complications were relatively rare. 1pt who did not take antibiotic as prescribed developed appendicitis, which required surgery 72hrs after procedure.1pt underwent elective surgery for a T2 cancer. Surgical specimen and lymph nodes showed no evidence of invasive cancer
Conclusion(s): Hybrid EMR-EFTR for colorectal lesions is a safe and effective for resection of lesions that are otherwise too large for EFTR alone.There were no adverse events related to deployment of the clip into tissue with EMR defect.This approach is a alternative to ESD or surgery. [Figure presented][Figure presented]
ISSN: 1097-6779
CID: 3932862


Hoerter, N A; Skup, M; Sofia, Yuen P Y; Vareedayah, A A; Haber, G B
Introduction: The incidence of duodenal polyps is approximately 1% in retrospective studies and up to 4.6% in one prospective study. Resection of suspected adenomas is recommended as they have a high incidence of development of high grade dysplasia or cancer. Endoscopic resection is associated with high rates of bleeding and perforation. Technical complexity, including involvement of the major papilla need for forward and side- viewing endoscopes, and angulation of the folds makes complete resection challenging. We present a large cohort of duodenal polyp resections including large complex polyps to emphasize complications and to provide recommendation for best clinical practice.
Aim(s): To evaluate the overall safety and efficacy of endoscopic resection of duodenal polyps Methods: A retrospective review of a database of duodenal polyps resected by a single endoscopist (GBH)between June 2016 and November 2018 was performed. The database includes ampullary and non-ampullary and sporadic or genetic syndrome associated (Familial adenomatous polpyposis, Peutz-Jeghers)polyps. Polyps resected by cold biopsy were excluded. This is a descriptive study which includes patient demographics, polyp size and location, resection technique, pathology, complications, and recurrence.
Result(s): The study included 69 procedures to remove 80 polyps total. Size ranged from 0.5cm to 7.0cm and 41 (51%)of the polyps were greater than 2 cm. Endoscopic technique was predominantly snare mucosal resection. Polyps greater than 5cm were generally not resected in a single procedure due to risk of complications and by intention underwent serial resection procedures. Intraprocedural bleeding occurred in 13% of procedures and was controlled entirely endoscopically. Post-polypectomy bleeding occurred in 10% and was managed either endoscopically or conservatively in all cases without surgery. Among larger polyps >2cm, the post-polypectomy bleeding rate was 12.5%. No bleeding was seen in the 22 polypectomy defects closed with clips. A total of three perforations occurred. One required surgical management, one was closed with an over-the-scope clip, and one was closed with a combination of endoscopic sutures and clips. Two patients underwent surgery for incomplete endoscopic resection. Follow up data was available for 27 patients with a mean of 10 months. Excluding the 5 patients who underwent serial procedures to complete resection, there were 7 recurrences out of 22 complete resections (32%).
Conclusion(s): This large series shows that duodenal polyp resection can be successfully performed with appropriate precautions. In contradistinction to the colon, there is little disadvantage to multiple sessions to reduce bleeding risk. Closure of defects with clips when feasible reduces the risk of bleeding. All patients with unclosed defects greater than 2cm should be admitted for overnight observation. [Figure presented][Figure presented]
ISSN: 1097-6779
CID: 3932902

What Constitutes Optimal Management of T1N0 Esophageal Adenocarcinoma?

Ramay, Fariha H; Vareedayah, Ashley A; Visrodia, Kavel; Iyer, Prasad G; Wang, Kenneth K; Eluri, Swathi; Shaheen, Nicholas J; Reddy, Rishindra; Martin, Linda W; Greenwald, Bruce D; Edwards, Melanie A
PURPOSE AND DESIGN/OBJECTIVE:Esophageal adenocarcinoma (EAC) develops as a consequence of gastroesophageal reflux disease and Barrett's esophagus (BE). While combination therapy with chemotherapy or concurrent chemoradiotherapy followed by esophagectomy improves survival in more advanced tumors, the optimal treatment strategy for early-stage EAC is undefined. Endoscopic eradication therapy, consisting of endoscopic resection and mucosal ablation, has revolutionized therapy for superficial (T1a) EAC in BE and allows for esophageal preservation in appropriate patients at low risk for lymph node metastasis (LNM). This review critically examines the literature regarding evaluation, treatment, and outcomes in patients with T1 EAC. METHODS:The literature was queried via the PubMed database to include articles published between 1990 and 2017. Search terms were generated from the key statements "Endoscopic eradication therapy results in equivalent overall survival when compared to esophagectomy for clinical T1aN0 EAC" and "Esophagectomy provides better overall survival than endoscopic eradication therapy for cT1b EAC". Abstracts were reviewed and included according to predefined selection and exclusion criteria, and were then assessed according to the GRADE system. RESULTS AND CONCLUSIONS/CONCLUSIONS:In patients with T1aN0 EAC, overall survival with endoscopic eradication therapy is equal to esophagectomy. Given the substantial risk of LNM in patients with submucosal (T1b) EAC, esophagectomy remains the standard of care for surgical candidates. In the case of inoperability or low-risk lesions, endoscopic resection may be considered adequate therapy. Chemotherapy and radiation can be offered as primary therapy for non-surgical candidates with lesions not amenable to endoscopic therapy, but does not have a clear role in the adjuvant setting after either endoscopic or surgical resection.
PMID: 30607765
ISSN: 1534-4681
CID: 3681042