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Expert consensus on endoscopic papillectomy using a Delphi process

Fritzsche, Jeska A; Fockens, Paul; Barthet, Marc; Bruno, Marco J; Carr-Locke, David L; Costamagna, Guido; Coté, Gregory A; Deprez, Pierre H; Giovannini, Marc; Haber, Gregory B; Hawes, Robert H; Hyun, Jong Jin; Itoi, Takao; Iwasaki, Eisuke; Kylänpaä, Leena; Neuhaus, Horst; Park, Jeong Youp; Reddy, D Nageshwar; Sakai, Arata; Bourke, Michael J; Voermans, Rogier P
BACKGROUND AND AIMS/OBJECTIVE:Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process. METHODS:Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement. RESULTS:Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%). CONCLUSIONS:This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies.
PMID: 33887269
ISSN: 1097-6779
CID: 5003602

External validation of blue light imaging (BLI) criteria for the optical characterization of colorectal polyps by endoscopy experts

Desai, Madhav; Kennedy, Kevin; Aihara, Hiroyuki; Van Dam, Jacques; Gross, Seth; Haber, Gregory; Pohl, Heiko; Rex, Douglas; Saltzman, John; Sethi, Amrita; Waxman, Irving; Wang, Kenneth; Wallace, Michael; Repici, Alessandro; Sharma, Prateek
BACKGROUND AND AIM/OBJECTIVE:Recently, the BLI Adenoma Serrated International Classification (BASIC) system was developed by European experts to differentiate colorectal polyps. Our aim was to validate the BASIC classification system among the US-based endoscopy experts. METHODS:Participants utilized a web-based interactive learning system where the group was asked to characterize polyps using the BASIC criteria: polyp surface (presence of mucus, regular/irregular and [pseudo]depressed), pit appearance (featureless, round/non-round with/without dark spots; homogeneous/heterogeneous distribution with/without focal loss), and vessels (present/absent, lacy, peri-cryptal, irregular). The final testing consisted of reviewing BLI images/videos to determine whether the criteria accurately predicted the histology results. Confidence in adenoma identification (rated "1" to "5") and agreement in polyp (adenoma vs non-adenoma) identification and characterization per BASIC criteria were derived. Strength of interobserver agreement with kappa (k) value was reported for adenoma identification. RESULTS:Ten endoscopy experts from the United States identified conventional adenoma (vs non-adenoma) with 94.4% accuracy, 95.0% sensitivity, 93.8% specificity, 93.8% positive predictive value, and 94.9% negative predictive value using BASIC criteria. Overall strength of interobserver agreement was high: kappa 0.89 (0.82-0.96). Agreement for the individual criteria was as follows: surface mucus (93.8%), regularity (65.6%), type of pit (40.6%), pit visibility (66.9%), pit distribution (57%), vessel visibility (73%), and being lacy (46%) and peri-cryptal (61%). The confidence in diagnosis was rated at high ≥4 in 67% of the cases. CONCLUSIONS:A group of US-based endoscopy experts hsave validated a simple and easily reproducible BLI classification system to characterize colorectal polyps with >90% accuracy and a high level of interobserver agreement.
PMID: 33928679
ISSN: 1440-1746
CID: 4873832

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

Initial Multicenter Experience Using a Novel Endoscopic Tack and Suture System for Challenging Gastrointestinal Defect Closure and Stent Fixation [Meeting Abstract]

Mahmoud, Tala; Song, Louis Wong Kee; Alansari, Tarek; Stavropoulos, Stavros; Ramberan, Hemchand; Fukami, Norio; Marya, Neil B. B.; Rau, Prashanth; Marshall, Christopher; Ghandour, Bachir; Bejjani, Michael; Khashab, Mouen A.; Haber, Gregory; Aihara, Hiroyuki; Antillon-Galdamez, Mainor R.; Chandrasekhara, Vinay; Abu Dayyeh, Barham K.; Storm, Andrew C.
ISI:000717526102007
ISSN: 0002-9270
CID: 5305372

Robotic-Assisted Endoscopic Submucosal Dissection of Distal Colon and Rectal Lesions [Meeting Abstract]

Cui, Y; Hartz, K M; Bernstein, M; Obias, V; Mathew, A; Bardakcioglu, O; Horner, L; Shah, P; Kim, S; Haber, G; Gross, S A
INTRODUCTION: Endoscopic submucosal dissection (ESD) and endoscopic full-thickness resection (EFTR) are therapeutic alternatives to surgery for resection of colon and rectal lesions. In regards to large colon and rectal polyps and tumors, both ESD and EFTR have high en bloc resection rates and low recurrence rates, but are limited by training, procedure length, stability, and instrumentation. The Robotic System (RS) is a new robot-assisted endoscopic platform with multiple degrees of freedom allowing improved visualization, dexterity, and tissue manipulation with traction. This is the first U.S. experience assessing the feasibility and safety of robot-assisted ESD and EFTR in resection of distal colon and rectal lesions and its implication for polyps and tumors.
METHOD(S): This is a multicenter retrospective study from five institutions. Patients with distal colon or rectal lesions who underwent either ESD or EFTR with the RS were included. Each patient's clinical history, endoscopic findings, procedural records, and pathology records were reviewed.
RESULT(S): Forty-one patients underwent either ESD or EFTR with the RS for distal colon or rectal lesions, with an average total resection time of 135.0 minutes (s 62.8, n = 24). On average, lesions were 9.3 cm from the anal verge (range: 2 cm to 17 cm, n = 35) and were 30.0 mm in max diameter (range: 9 to 77 mm, n = 28). There were 13 (31.7%) neoplasms and 23 (56.1%) adenomatous polyps; other lesions included inflammatory polyps, diffuse nodular lymphoid hyperplasia, and granulation tissue-all were suspicious for malignancy. Neoplasms included 11 adenocarcinomas and 2 GISTs. Adenomatous polyps included 11 tubular adenomas and 11 tubulovillous adenomas. Twenty-nine out of 34 patients (85.3%) with either adenomatous polyps or adenocarcinoma were successfully removed with the RS alone. Of these, 23 (79.3%) demonstrated clean margins on pathology. Post-endoscopic complications included rectal pain and bleeding.
CONCLUSION(S): This report demonstrates a role of robotic endoscopy for the safe and effective treatment of natural orifice endoscopic surgical resection, with its benefits including traction and triangulation. As endoscopic surgery in the form of ESD evolves, refinement of the tools and techniques of the robotic platform will allow endoscopists to have shorter learning curves and resection of distal colon and rectal polyps and tumors to have higher negative margin rates, potentially allowing more endoscopists the ability to perform ESD
EMBASE:633657215
ISSN: 1572-0241
CID: 4720562

THE EFFICACY, SAFETY, AND LONG-TERM DURABILITY OF LUMEN-APPOSING METAL STENTS IN THE MANAGEMENT OF BENIGN LUMINAL STRICTURES [Meeting Abstract]

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]
Copyright
EMBASE:2006054318
ISSN: 1097-6779
CID: 4472152

HOT AVULSION IS A SAFE TECHNIQUE FOR REMOVAL OF VISIBLE RESIDUAL NEOPLASIA AFTER ENDOSCOPIC MUCOSAL RESECTION OF COLON POLYPS [Meeting Abstract]

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]
Copyright
EMBASE:2006054295
ISSN: 1097-6779
CID: 4480382

ENDOSCOPIC ULTRASOUND GUIDED GALLBLADDER DRAINAGE (EUS-GBD) WITH LUMEN APPOSING METAL STENTS (LAMS) IN PATIENTS WITH ACUTE CHOLECYSTITIS HAS EXCELLENT LONG-TERM OUTCOMES: A LARGE, MULTICENTER US STUDY [Meeting Abstract]

David, Yakira N.; Kakked, Gaurav; Dixon, Rebekah E.; Confer, Bradley; Shah, Ruchit N.; Khara, Harshit S.; Diehl, David L.; Krafft, Matthew R.; Shah-Khan, Sardar M.; Nasr, John Y.; Benias, Petros C.; Trindade, Arvind J.; Muniraj, Thiruvengadam; Aslanian, Harry R.; Chahal, Prabhleen; Rodriguez, John; Adler, Douglas G.; Dubroff, Jay; DeLatour, Rabia; Tzimas, Demetrios; Khanna, Lauren; Haber, Gregory B.; Goodman, Adam J.; Hoerter, Nicholas A.; Pandey, Nishi; Bakhit, Mena; Kowalski, Thomas E.; Loren, David E.; Chiang, Austin L.; Schlachterman, Alexander; Nieto, Jose; Deshmukh, Ameya A.; Ichkhanian, Yervant; El Halabi, M. A. A. N.; Khashab, Mouen A.; Kwon, Richard; Prabhu, Anoop; Hernandez, Ariosto; Storm, Andrew C.; Levy, Michael J.; Miller, Corey S.; Berzin, Tyler M.; Kushnir, Vladimir; Cosgrove, Natalie; Mullady, Daniel; Al-Shahrani, Abdullah; Rolston, Vineet; D\Souza, Lionel; Buscaglia, Jonathan M.; Bucobo, Juan Carlos; Kedia, Prashant; Kasmin, Franklin; Nagula, Satish; Kumta, Nikhil A.; DiMaio, Christopher J.
ISI:000545678400596
ISSN: 0016-5107
CID: 4826112

A NOVEL HYBRID TECHNIQUE USING ENDOSCOPIC MUCOSAL RESECTION (EMR)AND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR)FOR LARGE COLORECTAL NEOPLASMS UNRESECTABLE BY EMR ALONE [Meeting Abstract]

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]
Copyright
EMBASE:2002059992
ISSN: 1097-6779
CID: 3932862

THE HIGH RATE OF BLEEDING WITH DUODENAL POLYPECTOMY MANDATES A STRATEGY SPECIFIC TO THIS LOCATION [Meeting Abstract]

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]
Copyright
EMBASE:2002058981
ISSN: 1097-6779
CID: 3932902