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Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration

Shinn, Brianna; Boortalary, Tina; Raijman, Isaac; Nieto, Jose; Khara, Harshit S; Kumar, S Vikas; Confer, Bradley; Diehl, David L; El Halabi, Maan; Ichkhanian, Yervant; Runge, Thomas; Kumbhari, Vivek; Khashab, Mouen; Tyberg, Amy; Shahid, Haroon; Sarkar, Avik; Gaidhane, Monica; Bareket, Romy; Kahaleh, Michel; Piraka, Cyrus; Zuchelli, Tobias; Law, Ryan; Sondhi, Arjun; Kedia, Prashant; Robbins, Justin; Calogero, Cristina; Bakhit, Mena; Chiang, Austin; Schlachterman, Alex; Kowalski, Thomas; Loren, David
BACKGROUND AND AIMS/OBJECTIVE:EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. [1] The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. [2-3] The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS:We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes included other procedural adverse events such as bleeding and perforation. RESULTS:In total, 11 LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (OR, 5.36; 95% CI,1.29-22.24; p=0.021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS:Use of larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.
PMID: 33957105
ISSN: 1097-6779
CID: 4866672

Single pass, 1 needle actuation versus single pass 3 actuation technique for EUS-guided liver biopsy: a randomized prospective trial (with video)

Ching-Companioni, Rafael A; Johal, Amitpal S; Confer, Bradley D; Forster, Erin; Khara, Harshit S; Diehl, David L
BACKGROUND AND AIMS/OBJECTIVE:Several reports have validated endoscopic ultrasound-guided liver biopsy (EUS-LB) as safe and effective. Nineteen-gauge EUS aspiration (fine-needle aspiration [FNA]) or core (fine-needle biopsy [FNB]) needles are used, but different needle techniques can yield variable outcomes. Some data shows 1 pass (single liver puncture) with 1 actuation (one to-and-fro needle movement) may be enough to obtain a satisfactory specimen. However, there has not been a head-to-head comparison of single versus multiple needle actuations for EUS-LB. METHODS:This was a prospective randomized trial of EUS-LB in 40 patients comparing tissue yields and adequacy using 1 pass, 1 actuation (1:1) versus 1 pass 3 actuations (1:3) of an FNB needle. Primary outcome was number of complete portal triads (CPT). Secondary outcomes were length of the longest piece, aggregate specimen length, number of cores >9 mm, and adverse events (AEs). Computerized randomization determined selection (either 1:1 or 1:3 with fanning technique). Sample lengths were measured before pathologic processing. RESULTS:Both groups had similar demographics and indications for EUS-LB. All biopsies were adequate for pathological interpretation. Compared with 1:1, biopsies with 1:3 yielded more CPT (mean [SD] 17.25 [6.2] vs 24.5 [9.88]; p <0.008) and longer aggregate specimen length (6.89 cm [1.86] vs 12.85 cm [4.02]; p <0.001). AEs were not statistically different between the techniques. No severe AEs were noted. CONCLUSION/CONCLUSIONS:EUS-LB using 1:3 technique produced longer liver cores with more CPT than the 1:1 technique with an equivalent safety profile. Two needle passes are more likely to provide tissue adequacy according to American Association for the Study of Liver Diseases (AASLD) guidelines.
PMID: 33771557
ISSN: 1097-6779
CID: 4830252

Comparison of pancreatic cystic fluid glucose and carcinoembryonic antigen in the diagnosis of pancreatic mucinous cysts [Letter]

Confer, Bradley D; Iqbal, Umair; Diehl, David L
PMID: 34148575
ISSN: 1097-6779
CID: 4918042

EUS-Directed Transgastric ERCP (EDGE): A Retrospective, Multicenter Study

Runge, Thomas M; Chang, Austin; Kowalski, Thomas E; James, Theodore W; Baron, Todd; Nieto, Jose; Diehl, David L; Krafft, Matthew Richard; Nasr, John Y; Kumar, Vikas; Khara, Harshit S; Irani, Shayan; Patel, Arpan; Law, Ryan; Loren, David E; Schlachterman, Alexander; Hsueh, William; Confer, Bradley; Stevens, Tyler; Chahal, Prabhleen; Al-Haddad, Mohammad; Mir, Fahad Faisal; Pleskow, Douglas; Huggett, Matthew T; Paranandi, Bharat; Trindade, Arvind Julius; Brewer Gutierrez, Olaya I; Ichkhanian, Yervant; Dbouk, Mohamad; Kumbhari, Vivek; Khashab, Mouen A
BACKGROUND AND STUDY AIMS/OBJECTIVE:Endoscopic ultrasound-directed transgastric ERCP (EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. Aims of this study were 1) to determine rates of long-term adverse events (AEs) after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; 2) identify predictors of persistent fistula; 3) assess outcomes of endoscopic closure when persistent fistula is encountered. PATIENTS AND METHODS/METHODS:This was a multicenter, retrospective study involving 13 centers between 1/2014 and 3/2019. AEs were defined according to ASGE lexicon. Persistent fistula was defined as upper GI series or EGD showing evidence of fistula. RESULTS:A total of 178 patients (mean age 58 years, 79% F) underwent EDGE. Technical success was achieved in 98% of cases (175/178) with a mean procedure time of 92 min. Periprocedural AEs occurred in 28 patients (15.7%; mild 10.1%, moderate 3.3%, severe 2.2%). The 4 severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10% of those sent for objective testing (9/90). Following identification of fistula, 5/9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS:The EDGE procedure is associated with high clinical success rates, and an acceptable risk profile. Persistent fistula after lumen apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistula are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.
PMID: 32882722
ISSN: 1438-8812
CID: 4588482

Endoscopy-guided percutaneous stapled pancreatic cystgastrostomy and necrosectomy

Khara, Harshit S; Gabrielsen, Jon D; Diehl, David L; Horsley, Ryan D
PMID: 32877935
ISSN: 1438-8812
CID: 4583372

Artificial intelligence applications in EUS: the journey of a thousand miles begins with a single step [Editorial]

Diehl, David L
PMID: 33685626
ISSN: 1097-6779
CID: 4809152

Artificial intelligence for early detection of pancreatic adenocarcinoma: The future is promising

Mendoza Ladd, Antonio; Diehl, David L
Pancreatic ductal adenocarcinoma (PDAC) is a worldwide public health concern. Despite extensive research efforts toward improving diagnosis and treatment, the 5-year survival rate at best is approximately 15%. This dismal figure can be attributed to a variety of factors including lack of adequate screening methods, late symptom onset, and treatment resistance. Pancreatic ductal adenocarcinoma remains a grim diagnosis with a high mortality rate and a significant psy-chological burden for patients and their families. In recent years artificial intelligence (AI) has permeated the medical field at an accelerated pace, bringing potential new tools that carry the promise of improving diagnosis and treatment of a variety of diseases. In this review we will summarize the landscape of AI in diagnosis and treatment of PDAC.
PMCID:8015296
PMID: 33833482
ISSN: 2219-2840
CID: 4839622

PRACTICE PATTERNS, TECHNIQUES, AND OUTCOMES OF FLEXIBLE ENDOSCOPIC MYOTOMY FOR ZENKER'S DIVERTICULUM: RETROSPECTIVE, MULTI-CENTER STUDY

Mittal, Chetan; Diehl, David; Draganov, Peter; Jamil, Laith; Khalid, Ammara; Khara, Harshit; Khullar, Vikas; Law, Ryan; Lo, Simon; Mathew, Abraham; Mirakhor, Ebrahim; Sedarat, Alireza; Sharma, Neil; Sharzehi, Setareh; Tavvakoli, Anna; Thaker, Adarsh; Thosani, Nirav; Yang, Dennis; Zelt, Christina; Wagh, Mihir S
BACKGROUND AND AIMS/OBJECTIVE:Flexible endoscopic myotomy has been increasingly performed for Zenker's diverticulum (ZD) using various endoscopic techniques and devices. The main aim of this study was to assess practice patterns and compare outcomes of endoscopic myotomy for ZD. PATIENTS AND METHODS/METHODS:Cases performed at 12tertiaryendoscopy centers from 1/2012-12/2018 were reviewed. Patients ≥18 years old with dysphagia and/or regurgitation, and ZD who underwent endoscopic myotomy were included. Outcomes assessed included technical success, clinical success and adverse events. RESULTS:161 patients were included. Traditional endoscopic septotomy was most commonly performed (137/161, 85.1%) followed by submucosal dissection on the septum and myotomy (24/161, 14.9%). Hook knife (43/161, 26.7%) and needle knife (33/161, 20%) were most commonly used. Overall, technical and clinical success was 98.1% (158/161) and78.1% (96/123). Adverse events were noted in 13patients (8.1%). There was no significant difference in technical and clinical success between traditional septotomy and submucosal dissection groups (97% vs 95.8%, p = 0.559 and 75.2% vs 90.9%, p = 0.155, respectively). Clinical success was higher with hook knife (96.67%), compared to needle knife (76.6%) and insulated tip knife (47.1%). Outcomes were similar between centers with > 20, 11-20 and <10 cases performed. CONCLUSIONS:Flexible endoscopic myotomy is an effective therapy for ZD with a low rate of adverse events. There was no significant difference in outcomes between traditional septotomy and a submucosal dissection approach, or with centers with higher volume, though clinical success was higher with the hook knife.
PMID: 32663877
ISSN: 1438-8812
CID: 4529092

A large multicenter cohort on the use of full-thickness resection device for difficult colonic lesions

Ichkhanian, Y; Vosoughi, K; Diehl, D L; Grimm, I S; James, T W; Templeton, A W; Hajifathalian, K; Tokar, J L; Samarasena, J B; Chehade, N El Hage; Lee, J; Chang, K; Mizrahi, M; Barawi, M; Irani, S; Friedland, S; Korc, P; Aadam, A A; Al-Haddad, M A; Kowalski, T E; Novikov, A; Smallfield, G; Ginsberg, G G; Oza, V M; Panuu, D; Fukami, N; Pohl, H; Lajin, Michael; Kumta, N A; Tang, S J; Naga, Y M; Amateau, S K; Brewer, G O I; Kumbhari, V; Sharaiha, R; Khashab, Mouen A
BACKGROUND:Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA. METHODS:Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE). RESULTS:A total of 95 patients (mean age 65.5 ± 12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5 ± 6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7 ± 31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention. CONCLUSIONS:Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.
PMID: 32180001
ISSN: 1432-2218
CID: 4361142

Evaluating learning curves and competence in colorectal endoscopic mucosal resection among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis

Yang, Dennis; Perbtani, Yaseen B; Wang, Yu; Rumman, Amir; Wang, Andrew Y; Kumta, Nikhil A; DiMaio, Christopher J; Antony, Andrew; Trindade, Arvind J; Rolston, Vineet S; D'Souza, Lionel S; Corral Hurtado, Juan E; Gomez, Victoria; Pohl, Heiko; Draganov, Peter V; Beyth, Rebecca J; Lee, Ji-Hyun; Cheesman, Antonio; Uppal, Dushant S; Sejpal, Divyesh V; Bucobo, Juan C; Wallace, Michael B; Ngamruengphong, Saowanee; Ajayeoba, Olumide; Khara, Harshit S; Diehl, David L; Jawaid, Salmaan; Forsmark, Christopher E
BACKGROUND AND AIMS/OBJECTIVE:Data on colorectal endoscopic mucosal resection (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT). METHODS:Multicenter prospective study using the STAT to grade AEFs training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship. RESULTS:Six AEFs (189 C-EMRs; mean 31.5±18.5 per AEF) were included. Mean polyp size and procedure time were 24.3±12.6 mm and 22.6±16.1 minutes, respectively. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All six AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs. CONCLUSION/CONCLUSIONS:A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relative low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. This pilot data serves as an initial framework for competence thresholds, and suggests the need for validated tools for formal C-EMR training assessment.
PMID: 32961243
ISSN: 1097-6779
CID: 4605662