Expert consensus on endoscopic papillectomy using a Delphi process.

BACKGROUND AND AIMS: 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.

Use of Artificial Intelligence to Reduce Radiation Exposure at Fluoroscopy-Guided Endoscopic Procedures.

OBJECTIVES: Exposure to ionizing radiation remains a hazard for patients and healthcare providers. We evaluated the utility of an artificial intelligence (AI)-enabled fluoroscopy system to minimize radiation exposure during image-guided endoscopic procedures. METHODS: We conducted a prospective study of 100 consecutive patients who underwent fluoroscopy-guided endoscopic procedures. Patients underwent interventions using either conventional or AI-equipped fluoroscopy system that uses ultrafast collimation to limit radiation exposure to the region of interest. The main outcome measure was to compare radiation exposure with patients, which was measured by dose area product. Secondary outcome was radiation scatter to endoscopy personnel measured using dosimeter. RESULTS: Of 100 patients who underwent procedures using traditional (n = 50) or AI-enabled (n = 50) fluoroscopy systems, there was no significant difference in demographics, body mass index, procedural type, and procedural or fluoroscopy time between the conventional and the AI-enabled fluoroscopy systems. Radiation exposure to patients was lower (median dose area product 2,178 vs 5,708 mGym, P = 0.001) and scatter effect to endoscopy personnel was less (total deep dose equivalent 0.28 vs 0.69 mSv; difference of 59.4%) for AI-enabled fluoroscopy as compared to conventional system. On multivariate linear regression analysis, after adjusting for patient characteristics, procedural/fluoroscopy duration, and type of fluoroscopy system, only AI-equipped fluoroscopy system (coefficient 3,331.9 [95% confidence interval: 1,926.8-4,737.1, P < 0.001) and fluoroscopy duration (coefficient 813.2 [95% confidence interval: 640.5-985.9], P < 0.001) were associated with radiation exposure. DISCUSSION: The AI-enabled fluoroscopy system significantly reduces radiation exposure to patients and scatter effect to endoscopy personnel (see Graphical abstract, Supplementary Digital Content, http://links.lww.com/AJG/B461).

Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience.

It has been 10 years since peroral endoscopic myotomy (POEM) was reported for the first time, and POEM has currently become the standard treatment for achalasia and related disorders globally because it is less invasive and has a higher curative effect than conventional therapeutic methods. However, there are limited studies comparing the long-term outcomes of POEM with those of conventional therapeutic methods, particularly in the occurrence of gastroesophageal reflux disease (GERD) after therapy. With this background, we held a consensus meeting to discuss the pathophysiology and management of GERD after POEM based on published papers and experiences of each expert and to discuss the prevention of GERD and dealing with anti-acid drug refractory GERD. This meeting was held on April 27, 2018 in Tokyo to establish statements and finalize the recommendations using the modified Delphi method. This manuscript presents eight statements regarding GERD after POEM.

EUS-guided celiac ganglion radiofrequency ablation versus celiac plexus neurolysis for palliation of pain in pancreatic cancer: a randomized controlled trial (with videos).

BACKGROUND AND AIMS: Although EUS-guided celiac plexus neurolysis (EUS-CPN) is frequently performed, its efficacy for palliation of pain in pancreatic cancer is suboptimal. Recently, EUS-guided radiofrequency ablation (EUS-RFA) has been proposed as a palliative treatment option for pancreatic neoplasms. We performed a single-blind, randomized trial to compare the effectiveness of EUS-CPN and EUS-RFA for palliation of pain in pancreatic cancer. METHODS: Patients with abdominal pain because of locally advanced or metastatic pancreatic cancer underwent EUS-CPN (n = 14) or EUS-RFA (n = 12). EUS-RFA was performed using a 1F monopolar probe passed via a 19-gauge FNA needle, by targeting the area of celiac plexus or visualized ganglia. Primary outcome was pain severity as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire pancreatic cancer module (PAN26) administered pretreatment and at 2 and 4 weeks post-treatment. Secondary outcome measures were comparison of quality of life as determined by the PAN26 and EORTC Quality of Life Questionnaire core questionnaire (C30) and opioid analgesia use between the 2 groups. RESULTS: Both the PAN26 (49.0 vs 57.0, P < .001) and C30 (51.9 vs 64.4, P = .032) revealed less pain for EUS-RFA than for EUS-CPN. Also, the EUS-RFA cohort experienced significantly less-severe GI symptoms, were able to plan more for the future, and had better emotional functioning compared with the EUS-CPN group. CONCLUSIONS: Compared with EUS-CPN, EUS-RFA provided more pain relief and improved the quality of life for patients with pancreatic cancer. (Clinical trials registration number: NCT03152487.).

An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis.

BACKGROUND & AIMS: Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis. METHODS: We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up. RESULTS: The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039). CONCLUSIONS: In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.

Utility of rapid onsite evaluation of touch imprint cytology from endoscopic and cholangioscopic forceps biopsy sampling (with video).

BACKGROUND AND AIMS: Rapid onsite evaluation of touch imprint cytology (ROSE-TIC) is a simple and rapid method used for the diagnosis of benign and malignant lesions. We evaluated the diagnostic accuracy of ROSE-TIC for advanced intestinal luminal and indeterminate pancreatobiliary lesions during endoscopy. METHODS: This is a retrospective descriptive study of patients who underwent endoscopy or ERCP between January 1, 2014 and December 31, 2016. It included patients who were referred for the treatment of intestinal luminal lesions or evaluation of indeterminate pancreatobiliary lesions. The slides were prepared by gently touching the specimen onto a glass slide and were examined under the microscope. The main outcome measure was to determine the diagnostic accuracy of ROSE-TIC by comparing the onsite cytology findings with the corresponding off-site histologic diagnosis. RESULTS: All 222 patients (106 pancreatobiliary and 116 GI lesions) had a prior benign diagnosis of intestinal luminal lesions or indeterminate diagnosis of pancreatobiliary lesions. The overall sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of ROSE-TIC were 97%, 85%, 83%, 97.2%, and 90%, respectively. The accuracy varied with the site of the biopsy sample. The accuracy was lowest for upper GI tract, where it was 85.2% but was 95% for lower GI tract lesions. CONCLUSIONS: By establishing a rapid onsite diagnosis, ROSE-TIC expedites decision-making on patient management. Prospective studies are needed to confirm these preliminary findings.

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.

BACKGROUND: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. METHODS: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. RESULTS: In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. CONCLUSIONS: Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.

Endoscopic Evaluation and Management of Gastric Stromal Tumors.

OPINION STATEMENT: Purpose of Review Gastrointestinal stromal tumors (GISTs) are both relatively common. Management of these lesions has been challenging with emerging interest in the endoscopic approach for both diagnostic and therapeutic interventions. Recent Findings Although these can be visualized on CT scan, endoscopic ultrasound (EUS) represents the standard method of evaluation and characterization using fine needle aspiration cytology (FNA) when indicated. While EUS-FNA can yield diagnostic cells, full characterization requires a sufficient volume of viable cells to do molecular analysis for c-KIT and determine the mitotic index. A new generation of fine needle biopsy (FNB) needles holds promise for improving our ability to fully characterize these lesions which will hopefully lead to improved management. Very small GISTs (< 1 cm) can probably be ignored, those between 1 and 2 cm are often surveyed, and those > 2 cm should be resected if the patient is fit and the lesion is in an accessible location. Though laparoscopic wedge resection is considered the standard of care, for small GISTs, those that are endophytic and/or located in a difficult position, pure endoscopic or hybrid laparoscopic-endoscopic approaches offer promise. Summary This review highlights the emerging advanced endoscopic approaches to GISTs. Although endoscopic removal of GISTs has two major advantages-precise localization of the lesion and gastric preservation, best practice strategies should focus on available expertise of expert endoscopists.

Lumen-apposing metal stents for drainage of pancreatic fluid collections: When and for whom?

BACKGROUND AND AIM: Although lumen-apposing metal stents (LAMS) are increasingly being used for drainage of pancreatic fluid collections (PFC), their advantage over plastic stents is unclear. METHODS: In this retrospective case-control study, 20 patients who underwent PFC drainage using LAMS were matched with 40 patients treated with plastic stents according to PFC type (walled-off necrosis [WON] vs pseudocyst) and procedural technique (conventional vs multi-gate). Main outcome measures were treatment success, reintervention, clinical and stent-related adverse events, procedural duration, length of hospital stay (LOS) and hospital costs. RESULTS: At median follow up of 570 days, except for median procedural duration (8.5 vs 25 min, P < 0.001), there was no significant difference in treatment success (95.0 vs 92.5%, P = 0.99), reintervention (25.0 vs 30.0 %, P = 0.77), clinical (10.0 vs 12.5 %, P = 0.99) and stent-related adverse events (10.0 vs 2.5 %, P = 0.26) or median LOS (2 [IQR 1-5] vs 2 [IQR 1-7] days, P = 0.58) between patients treated with LAMS versus plastic stents. Although there was no difference for WON ($16 708 for LAMS vs $17 221 for plastic stents, P = 0.90), mean hospital costs were significantly lower for pseudocysts using plastic stents ($18 996 vs $58 649, P = 0.03). CONCLUSIONS: Although there is no difference in clinical outcomes, treating pseudocysts using plastic stents is less expensive. It is also possible that the short procedural duration is a surrogate marker for procedural complexity and this may drive the use of LAMS in sicker patients.

Efficacy and safety of endoscopic mucosal resection of non-ampullary duodenal polyps: a systematic review.

BACKGROUND AND AIMS: Data on the safety and efficacy of endoscopic resection of non-ampullary duodenal polyps are limited. This study evaluated the safety and efficacy of endoscopic mucosal resection (EMR) of sporadic non-ampullary duodenal polyps. METHODS: Relevant studies for the meta-analysis were identified through search of PUBMED and EMBASE databases. Studies employing EMR for the management of sporadic duodenal polyps in the non-ampullary region were included. The primary outcome was the surgical intervention rates due to non-curative endoscopic resection (incomplete removal/recurrence necessitating surgery) and/or management of procedural adverse events. RESULTS: A total of 440 patients (485 duodenal polyps) from 14 studies were included. The mean size of the polyps was 13 mm to 35 mm. Surgical intervention due to non-curative EMR and adverse events was required in 2 % (95 % confidence interval [CI] 0 - 4 %). EMR was successfully accomplished in 93 % (95 %CI 89 - 97 %). The overall bleeding rate after EMR was 16 % (95 %CI 10 - 23 %), and the pooled delayed bleeding rate was 5 % (95 %CI 2 - 7 %). The overall incidence of perforation was 1 % (95 %CI 1 - 3 %). Over a median follow-up period of 6 - 72 months, the recurrence rate after EMR was 15 % (95 %CI 7 - 23 %). Six studies (pooled recurrence 20 %, 95 %CI 14 - 27 %) reported on the outcomes of managing recurrent polyps, for which endoscopic removal was successful in 62 % (95 %CI 37 - 87 %). There was no procedure related mortality. CONCLUSION: EMR appears to be a safe and effective therapeutic option for management of sporadic non-ampullary duodenal polyps. Long-term endoscopic surveillance is required to manage and treat recurrent disease.

Lessons Learned from Traditional NOTES: A Historical Perspective.

The idea of natural orifice surgery was conceived by Kantsevoy and Kalloo in the late 1990s. A group of surgeons formed the Apollo Group in 1997. Their vision and mission were to impact the practice of therapeutic endoscopy through innovation in techniques and technologies. The concept of natural orifice surgery was introduced at the initial meeting held on Kiawah Island, South Carolina in 1998. The original concept of flexible endoscopic surgery involved per-oral passage of a flexible endoscope into the stomach followed by entrance into the peritoneal cavity via a gastrostomy.

Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video).

BACKGROUND AND AIMS: Digital cholangioscopes provide higher-resolution imaging of the pancreatobiliary tract compared with fiberoptic instruments. The role of a new, digital, single-operator cholangiopancreatoscopy (SOC) system for diagnosis and treatment of pancreatobiliary disorders in clinical practice is not known. METHODS: We performed a multicenter, observational study of 105 consecutive patients with suspected pancreatobiliary disorders. The main outcome measures were (1) sensitivity and specificity of SOC visual appearance and biopsies in the diagnosis of indeterminate biliary strictures and (2) achieving complete duct clearance in patients with biliary or pancreatic duct stones. RESULTS: A total of 98 cholangioscopy and 7 pancreatoscopy procedures were performed in 105 patients. Superior views of the ductal lumen and mucosa were obtained in all 44 patients with indeterminate biliary strictures. Among the 44 patients who underwent SOC-guided biopsies, the specimen was adequate for histologic evaluation in 43 patients (97.7%). The sensitivity and specificity of SOC visual impression for diagnosis of malignancy was 90% (95% confidence interval [CI], 69.9%-97.2%) and 95.8% (95% CI, 79.8%-99.3%), respectively. The sensitivity and specificity of SOC-guided biopsies for diagnosis of malignancy was 85% (95% CI, 64.0%-94.8%) and 100% (95% CI, 86.2%-100%). In patients with biliary or pancreatic duct stones (N = 36), complete duct clearance with stone removal in 1 session was accomplished in 86.1% of patients (31/36). Three patients (2.9%) experienced SOC-related adverse events that included cholangitis in 2 patients and postprocedure pancreatitis in 1 patient. CONCLUSIONS: SOC has become an integral part of the ERCP armamentarium and has high accuracy in the evaluation of indeterminate biliary strictures. Complete stone clearance was achieved in all but 1 patient with challenging biliary or pancreatic duct stones. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01815619.).

Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review.

BACKGROUND AND AIMS: Evaluation of indeterminate biliary strictures by brush cytology and intraductal biopsies is limited by low sensitivity. The utility of SpyGlass peroral cholangioscopy for diagnosis of malignant biliary strictures and cholangiocarcinoma (CCA), in particular, remains unclear. Our aim was to study the utility of SpyGlass peroral cholangioscopy and targeted biopsy for diagnosis of malignant biliary strictures and CCA. METHODS: In this systematic review, PubMed and Embase databases were reviewed for studies published to October 2014. The main outcomes of interest were sensitivity, specificity, and diagnostic odds ratio (DOR) of SpyGlass cholangioscopy in the diagnosis of malignant biliary strictures. RESULTS: The search yielded 10 studies involving 456 patients. The pooled sensitivity and specificity of cholangioscopy-guided biopsies in the diagnosis of malignant biliary strictures was 60.1% (95% confidence interval [CI], 54.9%-65.2%) and 98.0% (95% CI, 96.0%-99.0%), respectively. The pooled DOR to detect malignant biliary strictures was 66.4 (95% CI, 32.1-137.5). Four studies included patients who had previous negative imaging and brushings and/or intraductal biopsies. Among these 4 studies, the pooled sensitivity and specificity for diagnosis of malignant biliary strictures was 74.7% (95% CI, 63.3%-84.0%) and 93.3% (95% CI, 85.1%-97.8%), respectively. The pooled DOR was 46.0 (95% CI, 15.4-138.1). Only 1 study directly compared the yield of SpyBite biopsies with standard brushings and biopsies. SpyBite biopsies had a sensitivity of 76.5% compared with brushings (5.8%) and biopsies (29.4%). Six studies specifically reported the role of cholangioscopy with targeted biopsies in the diagnosis of CCA. The pooled sensitivity and specificity to detect CCA was 66.2% (95% CI, 59.7%-72.3%) and 97.0% (95% CI, 94.0%-99.0%), respectively. The pooled DOR to detect CCA was 79.7 (95% CI, 32.7-194.7). CONCLUSIONS: Our study suggests that SpyGlass cholangioscopy with SpyBite biopsies has moderate sensitivity for the diagnosis of malignant biliary strictures.

Training endosonographers in cytopathology: improving the results of EUS-guided FNA.

BACKGROUND: Although on-site cytopathology services have a significant impact on efficiency and accuracy of EUS-guided FNA (EUS-FNA), the availability of this service is variable. OBJECTIVE: To evaluate the impact of an intensive 2-day training program to educate endosonographers in EUS-related cytopathology. DESIGN: Pilot study. SETTING: Tertiary care medical center. SUBJECTS: Six endosonographers (5 male, median age, 35 years) with minimal previous cytopathology exposure comprised the study cohort. METHODS: Pre- and posttraining testing was administered. Training commenced with a cytopathology tutorial focusing on 4 performance measures: specimen adequacy, sample interpretation, specimen processing, and preliminary diagnosis. Eight live EUS-FNA cases were then performed, and study participants independently completed 4 questions based on performance measures for each case. The ability to independently smear and stain slides and operate a microscope was additionally assessed after a hands-on tutorial. MAIN OUTCOME MEASUREMENTS: Comparison of pretraining and posttraining scores, improvement in performance measures for live cases, and ability to independently handle specimens and operate a microscope. RESULTS: Compared with pretraining, mean posttraining test scores improved by 63% from 48 to 78 out of 100. Mean live case performance score was 95%. Performances improved from 89% on day 1 to 100% on day 2. After training, all endosonographers could independently smear/stain slides and operate a microscope. LIMITATIONS: Long-term impact is unclear. CONCLUSIONS: An intensive 2-day program was effective in training endosonographers in the basics of EUS-related cytopathology. Incorporating basic cytopathology in EUS fellowship curriculum will likely improve diagnostic performance of tissue acquisition procedures.

The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial.

BACKGROUND: When on-site cytopathology support is not available, EUS-guided fine needle aspiration (EUS-FNA) is performed for cell-block preparation to allow off-site interpretation. OBJECTIVE: To identify the number of passes required to obtain a diagnostic cell block by using a 25-gauge needle for sampling pancreatic masses. DESIGN: Randomized trial. SETTING: Tertiary care hospital. PATIENTS: Sixty-two patients with solid pancreatic mass lesions. INTERVENTIONS: EUS-FNA was performed by using a 25-gauge needle. After establishing a preliminary on-site diagnosis, patients were randomized to 2 or 4 FNA passes for a cell block. A cell block was evaluated by a pathologist blinded to on-site interpretation for the presence of a tissue pellet, histological core tissue size, and diagnostic accuracy. MAIN OUTCOME MEASUREMENTS: To determine the number of passes required to obtain a diagnostic cell block with a 25-gauge FNA needle. RESULTS: Sixty-two patients were randomized to undergo either 2 (n = 31) or 4 (n = 31) FNA passes for a cell block. Before randomization, an on-site diagnosis was established in all 62 patients (100%). The final diagnosis was adenocarcinoma in 45 (72.6%), neuroendocrine/other tumor in 7 (11.3%), and chronic pancreatitis in 10 (16.1%). There was no difference in the presence of a tissue pellet (93.5 vs 96.8%; P = .99), the median size of the histological core (0.006 vs 0.05 mm(2); P = .12), or the presence of a diagnostic cell block (80.6 vs 80.6%; P = .99) between patients randomized to 2 or 4 FNA passes, respectively. LIMITATIONS: Only pancreatic masses were evaluated. CONCLUSIONS: The 25-gauge FNA needle yielded a diagnostic cell block in only 81% of patients, irrespective of whether 2 or 4 FNA passes were performed. These findings have important implications for centers without on-site cytopathology services. (Clinical trial registration number NCT01809028.).