Endoscopic Ultrasound-Guided Ablation of Pancreatic Mucinous Cysts.

Endoscopic ultrasound (EUS) has rapidly evolved from a diagnostic to a therapeutic tool with applications for various pancreaticobiliary diseases. As part of this evolution, EUS-guided chemoablation for neoplastic pancreatic cysts is developing as a minimally invasive treatment option for appropriately selected mucinous cysts, which can spare patients major resective surgery and may reduce progression to pancreatic cancer. Chemotherapeutic cyst ablation has demonstrated encouraging complete resolution rates, while an alcohol-free chemoablation protocol has demonstrated a significant decrease in adverse events without a compromise to complete ablation rates when compared with previous alcohol-based protocols. Most pancreatic cysts are small, low risk, and best managed by surveillance per accepted guidelines. Cysts with features suggestive of overt malignancy are best discussed by a multidisciplinary committee, and surgery is considered if appropriate. However, for patients in the middle ground with cysts that are structurally suitable for chemoablation, alcohol-free chemoablation has been shown to allow effective, safe, and durable results especially for those who are not ideal operative candidates. EUS-guided alcohol-free chemoablation is promising and continues to evolve; however, as a relatively novel treatment option it has areas of uncertainty that will require further investigation and development.

Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

BACKGROUND AND AIMS: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. METHODS: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. RESULTS: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. CONCLUSION: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial.

BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

Does successful EUS-guided pancreatic cyst chemoablation safely allow reduction in the frequency of radiographic surveillance? Long-term follow-up of randomized prospective data.

BACKGROUND AND AIMS: EUS-guided pancreatic cyst chemoablation is safe and effective for appropriately selected patients; however, the proper frequency of radiographic surveillance after successful chemoablation is unknown. Here we report the long-term follow-up of two randomized, prospective, ChARM clinical trials. Additionally, the performance of a post-ablation reduced radiographic surveillance protocol was evaluated using clinical and economic outcomes and patient experience metrics. METHODS: Patients who successfully completed one of the two ChARM randomized control trials were evaluated for durability of response and clinical outcomes. Patients were eligible if two years or more of follow-up were available and complete. We calculated economic outcomes using Medicare allowable costs applicable to EUS, MRI, and outpatient clinic visits. We modeled costs of a patient followed by the ChARM Post-treatment Reduced Radiographic Surveillance Protocol compared with a similar patient followed under Fukuoka or ACG guidelines over 5 years. Additionally, patients under long-term surveillance in our clinic were interviewed via a 4 question Likert scale questionnaire. RESULTS: 52 patients were eligible and included in the study. At the most recent follow-up of the 52 patients, 36 (69.2%) achieved complete response, an additional 11 (21.2%) showed partial response, and only 5 (9.6%) with nonresponse. All patients were successfully reduced to annual or less surveillance without recurrence or the development of cyst associated malignancy. When compared with Fukukoa or ACG guidelines, a patient treated and followed under the ChARM Post-Treatment Reduced Radiographic Surveillance Protocol incurred a Medicare allowable cost of $7,200.00 versus $19,437.44 and $12,526.52 if untreated and followed under Fukukoa or ACG guidelines, respectively. The patient experience questionnaire was returned completed by 49 participants. CONCLUSIONS: The ChARM Post-Treatment Reduced Radiographic Surveillance Protocol safely allows a reduction in radiographic surveillance. A reduction in cost associated with cyst management under the ChARM protocol was shown when compared to management following Fukukoa or ACG guidelines. According to the questionnaire, most patients reported a moderate level of logistical and emotional burden associated with MRI surveillance, and a majority were in favor of reducing the frequency of radiographic surveillance if it can be done without a marked increase in oncologic risk.

EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos).

BACKGROUND AND AIMS: EMR is the mainstay of therapy for large colorectal polyps. Local recurrence after EMR is common and can be reduced using margin ablation. Our aim was to evaluate recurrence rates when using hybrid argon plasma coagulation (h-APC) ablation after EMR. METHODS: Adult patients (aged 18-89 years) undergoing EMR of nonpedunculated colorectal polyps ≥20 mm were enrolled in a prospective multicenter study. h-APC was used to ablate all defect margins and also the resection surface in selected cases. The primary study outcome was recurrence rates found during the first follow-up colonoscopy. Secondary outcomes were technical success and adverse event rates. RESULTS: EMR with h-APC ablation was used in 101 polyps (84 patients, 46.4% women). EMR with h-APC ablation was technically successful in all cases (median EMR time, 15 minutes; median h-APC ablation time, 4 minutes). Median polyp size was 30 mm (range, 20-60). Resected polyps were either adenomas (68/101 [67.3%]), sessile serrated lesions (27/101 [27%]), or adenocarcinomas (6/101 [6%]). The post-EMR recurrence rate was 2.2% (2/91) (95% confidence interval, .27-7.71). All 6 patients with cancer (intramucosal cancer, 4; T1sm cancer, 2) were found to have complete eradication of the primary tumor after EMR with h-APC, and none had lymph node metastasis. Four serious adverse events occurred in 3 patients (2 delayed bleeding [2.4%], 1 abdominal pain [1.2%], and 1 microperforation [1.2%]. All serious adverse events resolved with either endoscopic or antibiotic treatment only. CONCLUSIONS: EMR with h-APC showed a high technical success rate, low adverse event rate, and very low post-EMR recurrence rates. (Clinical trial registration number: NCT04015765.).

The Durability of EUS-Guided Chemoablation of Mucinous Pancreatic Cysts: A Long-Term Follow-Up of the CHARM trial.

Pancreatic cancer has known precursor lesions with potential to develop into malignancy over time. At least 20% of pancreatic cancer evolves from mucinous cystic neoplasms and intraductal papillary mucinous neoplasms, which are often discovered incidentally.1,2 Current guidelines for the management of mucinous cystic neoplasms and intraductal papillary mucinous neoplasms include long-term surveillance, which is expensive and nontherapeutic, or surgical resection, which is associated with major risk and may not be an option for patients with significant concomitant illness.3.

Hybrid argon plasma coagulation-assisted endoscopic mucosal resection for large sessile colon polyps to reduce local recurrence: a prospective pilot study.

BACKGROUND: Endoscopic mucosal resection (EMR) of large, sessile colon polyps often results in incomplete resection with subsequent recurrence. The aim of this prospective pilot study was to evaluate the efficacy and safety of a novel technique, hybrid argon plasma coagulation-assisted EMR (hAPC-EMR), to remove large, sessile polyps. METHODS: 40 eligible patients underwent hAPC-EMR for the removal of one or more nonpedunculated colon polyps ≥ 20 mm. Participants were contacted 30 days post-procedure to assess for adverse events and were recommended to return for a surveillance colonoscopy at 6 months to assess for local recurrence. RESULTS: At the time writing, 32 patients with 35 polyps (median size 27 mm; interquartile range 14.5 mm) resected by hAPC-EMR had undergone the 6-month follow-up colonoscopy. Recurrence rate was 0 % (95 % confidence interval [CI] 0-0) at follow-up. Post-polypectomy bleeding was experienced by three patients (7.5 %; 95 %CI 0.00-0.15), and no patients developed post-polypectomy syndrome. CONCLUSION: These preliminary results showed 0 % local recurrence rate at 6 months and demonstrated the safety profile of hAPC-EMR. A large, randomized, controlled trial is required to confirm these results.

Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial.

BACKGROUND & AIMS: Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). METHODS: In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. RESULTS: A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). CONCLUSION: The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. CLINICALTRIALS: gov, Number: NCT01936948.

Endoscopic hemostatic spray for uncontrolled bleeding after complicated endoscopic mucosal resection or endoscopic submucosal dissection: a report of 2 cases.

BACKGROUND AND AIMS: There is a significant bleeding risk after gastric endoscopic submucosal dissection (ESD) and EMR cases. This case series describes the use of an endoscopic hemostasis spray, which is not typically used to treat this type of bleeding, after multiple attempts with other modalities failed. METHODS: We present 2 patient cases of ESD and EMR used to treat a gastric adenoma (case 1) and 2 gastric hyperplastic masses (case 2) with refractory bleeding after use of multiple other treatment modalities. Both patients were not surgical candidates because of their medical comorbidities. RESULTS: Bleeding was eventually controlled with the use of endoscopic hemostasis spray after attempts were made using SB Knife Jr tip, Coagrasper Hemostatic Forceps, Argon Photocoagulation, and scope tamponade. CONCLUSIONS: In very specific cases, endoscopic hemostasis spray may have some utility for refractory bleeding after dissection of gastric lesions. After using this spray, it became technically challenging to suture endoscopically because of the mud-like quality of the hemostasis material.

Endoscopic resection of large Paris 0-Ip pedunculated polyps: video demonstration of recent U.S. Multi-Society Task Force recommendations on resection and removal for general endoscopists.

Video 1Illustration of general principles as well as different techniques that can be used for the ligation and resection of pedunculated polyps.

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps.

BACKGROUND AND STUDY AIM : Delayed bleeding is a common adverse event following endoscopic mucosal resection (EMR) of large colorectal polyps. Prophylactic clip closure of the mucosal defect after EMR of nonpedunculated polyps larger than 20 mm reduces the incidence of severe delayed bleeding, especially in proximal polyps. This study aimed to evaluate factors associated with complete prophylactic clip closure of the mucosal defect after EMR of large polyps. METHODS : This is a post hoc analysis of the CLIP study (NCT01936948). All patients randomized to the clip group were included. Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when no remaining mucosal defect was visible and clips were less than 1 cm apart. Factors associated with complete closure were evaluated in multivariable analysis. RESULTS : In total, 458 patients (age 65, 58 % men) with 494 large polyps were included. Complete clip closure of the resection defect was achieved for 338 polyps (68.4 %); closure was not complete for 156 (31.6 %). Factors associated with complete closure in adjusted analysis were smaller polyp size (odds ratio 1.06 for every millimeter decrease [95 % confidence interval 1.02-1.08]), good access (OR 3.58 [1.94-9.59]), complete submucosal lifting (OR 2.28 [1.36-3.90]), en bloc resection (OR 5.75 [1.48-22.39]), and serrated histology (OR 2.74 [1.35-5.56]). CONCLUSIONS : Complete clip closure was not achieved for almost one in three resected large nonpedunculated polyps. While stable access and en bloc resection facilitate clip closure, most factors associated with clip closure are not modifiable. This highlights the need for alternative closure options and measures to prevent bleeding.

Pancreatitis kills cysts: A phenomenon that illustrates the potential role of immune activation in premalignant cyst ablation.

Background and study aims Pancreatic cystic lesions are being increasingly recognized on cross-sectional imaging and mucinous premalignant cysts represent one of the most prevalent types. Endoscopic ultrasound (EUS)-guided chemoablation offers a safe and minimally invasive ablation approach yet with limited efficacy. Patients who develop acute pancreatitis as a complication of chemoablation with alcohol however experience ablation rates up to 100 %. This evidence suggests that recruitment of the body's immune system may represent an avenue to significantly increase the efficacy of EUS-guided chemoablation. Here we illustrate this immune-mediated tumor killing phenomenon through a case presentation at our institution.

Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial.

BACKGROUND & AIMS: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.

Endoscopic Management of Large Peripancreatic Fluid Collections in Two Pediatric Patients by Endoscopic Ultrasound-guided Transmural Drainage.

The incidence of acute pancreatitis (AP) has increased in the pediatric population over the past few decades and it stands to follow that the complications of severe AP, including symptomatic pancreatic fluid collections (PFCs) will increase as well. In adults, the therapeutic options for this situation have undergone a dramatic evolution from mainly surgical approaches to less invasive endoscopic approaches, mainly endoscopic ultrasound-guided transmural drainage (EUS-TD) followed be direct endoscopic necrosectomy if needed. This has proven safe and effective in adults; however, this approach has not been well studied or reported in pediatric populations. Here we demonstrate that EUS-TD seems to offer a safe, efficacious and minimally invasive approach to the management of large PFCs in pediatric patients by reviewing two representative cases at our institution.

Position statement on EUS-guided ablation of pancreatic cystic neoplasms from an international expert panel.

Background and aim Recently, several guidelines with divergent recommendations on management of pancreatic cystic neoplasm have been published but the role of endoscopic ultrasound (EUS)-guided pancreatic cyst ablation has not been thoroughly addressed. The aim of the current paper is to explore the issues surrounding EUS-guided pancreatic cyst ablation by generating a list of clinical questions and providing answers based on best scientific evidence available. Methods An expert panel in EUS-guided pancreatic cyst ablation was recruited from members of the Asian EUS group and an international expert panel. A list of clinical questions was created and each question allocated to one member to generate a statement in response. The statements were then discussed in three Internet conference meetings between October 2016 and October 2017. The statements were changed until consensus was obtained. Afterwards, the complete set of statements was sent to all the panelist to vote on strength of the statements, classification of the statement sand grading of the evidence. Results Twenty-three statements on EUS-guided drainage of pancreatic cyst ablation were formulated. The statements addressed indications for the procedures, technical aspects, pre-procedure and post-procedure management, management of complications, and competency and training in the procedures. Conclusion The current set of statements on EUS-guided pancreatic cyst ablation are the first to be published by any endoscopic society. Clinicians interested in developing the technique should reference these statements and future studies should address the key issues raised in the document.

Percutaneous debridement and washout of walled-off abdominal abscess and necrosis by the use of flexible endoscopy: an attractive clinical option when transluminal approaches are unsafe or not possible.

BACKGROUND AND AIMS: Walled-off pancreatic necrosis is a well-known serious adverse event of severe acute pancreatitis. EUS-guided transluminal access followed by direct endoscopic necrosectomy is increasingly used to remove necrosis, with good efficacy and a superior safety profile when compared with surgery. However, a percentage of patients is too critically ill to undergo this procedure or lack an appropriate transluminal window for access. Here we describe the use of percutaneous flexible endoscopic necrosectomy (PEN) with use of standard-sized upper endoscopes and accessories in a retrospective single-institution experience with a video demonstration of 1 patient in the series. METHODS: The authors present a 23-patient retrospective case series of PEN with standard-sized endoscopes. The series includes 12 patients from a previously published analysis in 2016 and 11 additional patients from 2013 to 2018. A representative case illustrates the described technique in a patient with severe acute pancreatitis complicated by multisystem organ failure who required immediate drainage of a pancreatic fluid collection and placement of a percutaneous drain into the collection for decompression. The drain was serially upsized to 28F, and its tract was used for PEN. RESULTS: A total of 23 patients have undergone PEN at our institution. On average, the size of the pancreatic fluid collection was 11.6 cm in cross-sectional diameter. Of those 23 patients, 11 presented with symptoms of severe disease. The median time from onset of symptoms to PEN was 84 days. The median number of procedures per patient was 2.1. The median time to complete resolution of symptoms and fluid collections was 67 days. In total, resolution was reached in 22 of 23 patients. Two patients died of unrelated causes. CONCLUSION: PEN is a minimally invasive and effective treatment approach to walled-off pancreatic necrosis in patients who are not amenable to transluminal drainage and in whom percutaneous drains have been successfully placed. This case series demonstrates the efficacy and safety of this approach. A randomized prospective trial would be warranted to validate these results.

Successful treatment of large cavity esophageal disruptions with transluminal washout and endoscopic vacuum therapy: a report of two cases.

Acute, high-grade esophageal perforation and postoperative leak after esophagogastrostomy are associated with high morbidity and mortality due to the development of mediastinitis and thoracic contamination. Endoscopic vacuum therapy has proven to be a feasible, safe therapy for management of esophageal wall defects, but with limited success. We describe a retrospective single-center analysis of two patients who underwent endoscopic vacuum therapy for significant esophageal disruptions with a median cross-sectional diameter of 10.7 cm. The technique involved the use of a standard upper video endoscope, nasogastric tube, and vacuum-assisted closure dressing kit, with endoscopic placement of a polyurethane sponge and nasogastric tube assembly into the mediastinal or thoracic cavity. Serial washout and debridement were performed prior to each sponge insertion. Data were collected on indication, size of the cavities, time to intervention, number of procedures, time to resolution, outcomes, and adverse events. Two patients underwent therapy with a mean age of 69.5. The median size of the collections via longest cross-sectional diameter was 10.7 cm. The average number of endoscopic vacuum therapy performed was six and average duration of therapy was 49 days. Complete resolution was achieved in both patients. One patient died 6 weeks later due to severe sepsis from aspiration pneumonia. Endoscopic washout and debridement followed by endoscopic vacuum therapy can be effective for large, even multiple, thoracic and mediastinal contaminations following esophageal perforation and gastroesopagheal anastomotic dehiscence and leaks in appropriately selected patients.