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Ampullary and biliary stenosis: a delayed sphincterotomy complication--easy to forget, tough to treat [Comment]

Haber, Gregory B
PMID: 17905012
ISSN: 0016-5107
CID: 1860222


Bhakta, D; De, Latour R; Haber, G B; Gross, S A; Janec, E; Saraceni, M; Khanna, L
Introduction: Pancreatic cystic lesions (PCL) are increasingly identified on cross-sectional imaging. Types include intraductal papillary mucinous neoplasms (IPMN), mucinous cystic neoplasms (MCN), serous cystadenoma (SCA), solid pseudopapillary tumors (SPT) and pseudocysts. Given the risk of malignancy associated with MCN and IPMN with high risk features, accurate PCL diagnosis is essential. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) of cyst fluid for cytology remains important for the classification of PCL, but is limited by the ability to obtain a sufficient sample and cellularity of fluid. The specificity for malignant cytology is 94%, but sensitivity remains low at 51%. Recently, introduction of a novel microforceps biopsy (MFB) device (Moray Micro Forceps, US Endoscopy, Mentor, OH) has enabled EUS-guided through-the-needle biopsies of PCL through a 19-gauge needle. The aim of this study is to compare the technical success and diagnostic yield for PCL using MFB versus cyst fluid studies alone, along with identifying adverse events associated with MFB.
Method(s): We conducted a retrospective chart review of adult patients with PCL diagnosed by cross sectional imaging undergoing EUS-guided FNA with MFB at 2 tertiary academic centers from November 2016 to November 2019. FNA of PCL was performed and cyst fluid was sent for cytology, carcinoembryonic antigen (CEA) levels, and mutational analysis. Cyst biopsy was performed using MFB.
Result(s): 14 patients were included. 71% were female. Median age was 60 years. Location of cysts in pancreas were head (4), body (6), and tail (4). MFB was technically successful in 12 of 14 cases (yield 86%) including 1 case where no cyst fluid was able to be obtained. There were no reported adverse outcomes (bleeding, pancreatitis, perforation, infection, abdominal pain). MFB diagnosed IPMN in 2 patients, neither of which were identified by cytology but were identified by fluid mutational analysis; MCN in 2 patients, 1 of which was identified by cytology; and SCA in 1 patient where cytology was concerning for a mucinous lesion. Both MFB and cytology were concerning for pseudocyst in 1 patient who ultimately was found to have MCN.
Discussion(s): The technical success of MFB is high and is associated with increased overall diagnostic yield without significant adverse events. For distinguishing PCL types, MFB provided additive diagnostic information to fluid cytology in 4 of 14 patients in our study. Including mutational analysis which identified IPMN in 2 patients where cytology was negative, MFB still provided further diagnostic information in 2 additional patients. This study suggests that the addition of MFB to EUS-guided sampling for cytology, CEA and mutational analysis further augments PCL diagnosis. Future studies should elucidate the role of MFB in combination with mutational analysis. [Formula presented]
ISSN: 0016-5107
CID: 4469932


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

Initial multicenter experience using a novel endoscopic tack and suture system for challenging GI defect closure and stent fixation (with video)

Mahmoud, Tala; Wong Kee Song, Louis M; Stavropoulos, Stavros N; Alansari, Tarek H; Ramberan, Hemchand; Fukami, Norio; Marya, Neil B; Rau, Prashanth; Marshall, Christopher; Ghandour, Bachir; Bejjani, Michael; Khashab, Mouen A; Haber, Gregory B; Aihara, Hiroyuki; Antillon-Galdamez, Mainor R; Chandrasekhara, Vinay; Abu Dayyeh, Barham K; Storm, Andrew C
BACKGROUND AND AIMS/OBJECTIVE:Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult to reach defects. Thus, we aimed to assess the feasibility and safety of the novel through-the-scope suture-based closure system that was developed to overcome these limitations. METHODS:This is a retrospective multicenter study involving 8 centers in the United States. Primary outcomes included feasibility and safety of early use of the device. Secondary outcomes included assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s). RESULTS:A total of 93 patients (48.4% female) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%) and supplemental closure was required in 24.7% (n=23) of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients due to location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of the cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range: 13-93.5 days) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred. CONCLUSIONS:The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large, and irregularly shaped defects that were not possible with predicate devices.
PMID: 34695421
ISSN: 1097-6779
CID: 5042262

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

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

Outstanding research award in the interventional endoscopy category (trainee) new automated cleaning system is more effective in reducing bioburden vs standard manual clean in duodenoscopes [Meeting Abstract]

O'Donnell, M; Goodman, A; De, Latour R; Poppers, D; Haber, G; Gross, S A
Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein<6.4 ug/cm^2 and carbohydrates<2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology.
Method(s): A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning.
Result(s): The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p= 0.03).
Conclusion(s): Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device-involving multiple channels and an elevator mechanism at the distal tip-makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes
ISSN: 1572-0241
CID: 5083872

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.
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
ISSN: 1572-0241
CID: 4720562