Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial.

BACKGROUND: Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis. METHODS: This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged ≥18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed. FINDINGS: Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0·0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6·1 percentage points [95% CI -16·5 to 4·5]; p=0·22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16·1 percentage points [-37·4 to 7·0]; p=0·17), nor procedure-related adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13·4 percentage points [-30·8 to 5·0]; p=0·14). INTERPRETATION: In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. FUNDING: None.

Basic and Advanced Biliary Cannulation: How Do I Do It?

Successful biliary cannulation of a native papilla is usually the rate-limiting step toward a successful ERCP. Standard cannulation techniques usually succeed, particularly when utilizing the wire-guided technique. There are, however, a myriad of confirmations of the major papilla as well as anatomic variants and certain pathologies which can make cannulation exceedingly difficult. For these cases, advanced cannulation techniques and techniques termed "access sphincterotomy" have been developed which should allow successful cannulation in >90% of cases. This article should help all those performing ERCP to improve their cannulation rate.

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.

Acute Pancreatitis Task Force on Quality: Development of Quality Indicators for Acute Pancreatitis Management.

INTRODUCTION: Detailed recommendations and guidelines for acute pancreatitis (AP) management currently exist. However, quality indicators (QIs) are required to measure performance in health care. The goal of the Acute Pancreatitis Task Force on Quality was to formally develop QIs for the management of patients with known or suspected AP using a modified version of the RAND/UCLA Appropriateness Methodology. METHODS: A multidisciplinary expert panel composed of physicians (gastroenterologists, hospitalists, and surgeons) who are acknowledged leaders in their specialties and who represent geographic and practice setting diversity was convened. A literature review was conducted, and a list of proposed QIs was developed. In 3 rounds, panelists reviewed literature, modified QIs, and rated them on the basis of scientific evidence, bias, interpretability, validity, necessity, and proposed performance targets. RESULTS: Supporting literature and a list of 71 proposed QIs across 10 AP domains (Diagnosis, Etiology, Initial Assessment and Risk Stratification, etc.) were sent to the expert panel to review and independently rate in round 1 (95% of panelists participated). Based on a round 2 face-to-face discussion of QIs (75% participation), 41 QIs were classified as valid. During round 3 (90% participation), panelists rated the 41 valid QIs for necessity and proposed performance thresholds. The final classification determined that 40 QIs were both valid and necessary. DISCUSSION: Hospitals and providers managing patients with known or suspected AP should ensure that patients receive high-quality care and desired outcomes according to current evidence-based best practices. This physician-led initiative formally developed 40 QIs and performance threshold targets for AP management. Validated QIs provide a dependable quantitative framework for health systems to monitor the quality of care provided to patients with known or suspected AP.

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.

EUS correlates of disconnected pancreatic duct syndrome in walled-off necrosis.

BACKGROUND AND STUDY AIMS: Although the diagnostic features of disconnected pancreatic duct syndrome (DPDS) by computed tomography (CT) and magnetic/endoscopic retrograde cholangiopancreatography (MRCP/ERCP) have been established, no such characterization exists for endoscopic ultrasound (EUS). This study describes the imaging features of EUS that accurately define DPDS. PATIENTS AND METHODS: This is a prospective study comprising 21 of 42 patients who underwent EUS-guided drainage of walled-off necrosis (WON) over an 18-month period. Findings on EUS were correlated with CT and pancreatography or surgical pathology when available. DPDS by EUS was defined by the presence of a well-defined fluid collection along the course of the main pancreatic duct with the upstream pancreatic parenchyma and duct terminating into the fluid collection. The main outcome measure was to assess the accuracy of EUS in diagnosing DPDS by correlation with CT and pancreatography or surgical pathology. RESULTS: Twenty-one patients with WON (median age 55 years; 15 males) constituted the study cohort. Median duration of pancreatitis was 12 weeks (range 5 - 20) and median WON size was 120 mm (range 40 mm to 200 mm). At EUS, the upstream pancreatic parenchyma and duct were found to terminate within the WON in all 21 patients in whom DPDS was subsequently confirmed by follow-up CT in all patients, by ERCP in 17, EUS-pancreatogram in 3 and surgical pathology in 1. There was 100 % correlation between EUS characterization of DPDS with CT and pancreatography or surgical pathology. CONCLUSIONS: We report EUS findings indicating the presence of DPDS. These findings may have significant clinical implications for the management of patients with WON.