Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study.

BACKGROUND AND AIMS: Recent Western studies support the safety and efficacy of endoscopic submucosal dissection (ESD) for lesions throughout the GI tract. Although admission for observation after ESD is standard in Asia, a more selective approach may optimize resource utilization. We aimed to evaluate the safety and feasibility of same-day discharge (SDD) after ESD and factors associated with admission. METHODS: This was a post hoc analysis of a multicenter, prospective cohort of patients undergoing ESD (2016-2021). The primary end points were safety of SDD and factors associated with post-ESD admission. RESULTS: Of 831 patients (median age, 67 years; 57% male) undergoing 831 ESDs (240 performed in the esophagus, 126 in the stomach, and 465 in the colorectum; median lesion size, 44 mm), 588 (71%) were SDD versus 243 (29%) admissions. Delayed bleeding and perforation occurred in 12 (2%) and 4 (.7%) of SDD patients, respectively; only 1 (.2%) required surgery. Of the 243 admissions, 223 (92%) were discharged after ≤24 hours of observation. Interestingly, larger lesion size (>44 mm) was not associated with higher admission rate (odds ratio [OR], .5; 95% confidence interval [CI], .3-.8; P = .001). Lesions in the upper GI tract versus colon (OR, 1.7; 95% CI, 1.1-2.6; P = .01), invasive cancer (OR, 1.9; 95% CI, 1.2-3.1; P = .01), and adverse events (OR, 2.7; 95% CI, 1.5-4.8; P = .001) were independent factors for admission. Admissions were more likely performed by endoscopists with ESD volume <50 cases (OR, 2.1; 95% CI, 1.3-3.3; P = .001) with procedure time >75 minutes (OR, 13.5; 95% CI, 8.5-21.3; P < .0001). CONCLUSIONS: SDD after ESD can be safe and feasible. Patients with invasive cancer, lesions in the upper GI tract, longer procedure times, or procedures performed by low-volume ESD endoscopists are more likely to be admitted postprocedure. Risk stratification of patients for SDD after ESD should help optimize resource utilization and enhance ESD uptake in the West. (Clinical trial registration number: NCT02989818.).

Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia.

BACKGROUND AND AIMS: Data are limited on the role of endoscopic submucosal dissection (ESD) as a potential diagnostic and staging tool in Barrett's esophagus (BE) neoplasia. We aimed to evaluate the frequency and factors associated with change of histologic diagnosis by ESD compared with pre-ESD histology. METHODS: This was a multicenter, prospective cohort study of patients who underwent ESD for BE visible neoplasia. A change in histologic diagnosis was defined as "upstaged" or "downstaged" if the ESD specimen had a higher or lower degree, respectively, of dysplasia or neoplasia when compared with pre-ESD specimens. RESULTS: Two hundred five patients (median age, 69 years; 81% men) with BE visible neoplasia underwent ESD from 2016 to 2021. Baseline histology was obtained using forceps (n = 182) or EMR (n = 23). ESD changed the histologic diagnosis in 55.1% of cases (113/205), of which 68.1% were upstaged and 31.9% downstaged. The frequency of change in diagnosis after ESD was similar whether baseline histology was obtained using forceps (55.5%) or EMR (52.2%) (P = .83). In aggregate, 23.9% of cases (49/205) were upstaged to invasive cancer on ESD histopathology. On multivariate analysis, lesions in the distal esophagus and gastroesophageal junction (odds ratio, 2.1; 95 confidence interval, 1.1-3.9; P = .02) and prior radiofrequency ablation (odds ratio, 2.5; 95% confidence interval, 1.2-5.5; P = .02) were predictors of change in histologic diagnosis. CONCLUSIONS: ESD led to a change of diagnosis in more than half of patients with BE visible neoplasia. Selective ESD can serve as a potential diagnostic and staging tool, particularly in those with suspected invasive disease. (Clinical trial registration number: NCT02989818.).

Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America. METHODS: We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection. RESULTS: Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). CONCLUSIONS: In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

Use of an Endoscopic Suturing Platform for the Management of Staple Line Dehiscence After Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Management of staple line dehiscence following laparoscopic sleeve gastrectomy (LSG) varies based on local expertise and timing of presentation. We present our experience with an endoscopic suturing platform to treat patients with staple line dehiscence following LSG. METHODS: We included all patients who presented to our institution with a staple line dehiscence following LSG from 2005 through November 2017. All endoscopic suturing procedures were performed by a single interventional endoscopist. RESULTS: Five patients, ages 25-69 years, received treatment of staple line dehiscence at a median time of 22 days following LSG (range 13-335 days). Four out of the five patients received a stent at some point during their treatment. One patient with a chronic leak required gastrectomy and esophago-jejunostomy as a definitive treatment. The remaining four patients experienced resolution of the leak at a median of 48 days post-operatively (range 21-82 days). CONCLUSION: Endoscopic suturing may have a role in the management of leaks following LSG, as a primary treatment or as an adjunct to treatment with a stent. However, given that the technique requires considerable endoscopic expertise and in light of a number of other available therapeutic choices, further studies are required to better define the role of this technology in the algorithm of LSG-related leak management.

Perivascular Epithelioid Cell Tumor (PEComa) of Pancreas Diagnosed Preoperatively by Endoscopic Ultrasound-Guided Fine-Needle Aspiration: A Case Report and Review of Literature.

Perivascular epithelioid cell tumors (PEComas) of the pancreas are extremely rare mesenchymal tumors and to our knowledge, only 17 cases have been reported in the English literature to date. We report our experience with a new case of primary pancreatic PEComa diagnosed preoperatively by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) complemented by tissue cell block and immunohistochemistry. The patient was a 54-year-old female whose chief complaint was intermittent severe right upper quadrant abdominal pain. Computed-tomography (CT) imaging revealed a mass between the head and the body of the pancreas. EUS-FNA smear preparation was obtained but was nondiagnostic. However, examination of the tissue cell block showed sheets of epithelioid cells with abundant eosinophilic cytoplasm and immunohistochemistry studies revealed positivity for both melanocytic (HMB-45 and Melan-A) and smooth muscle markers (actin and desmin). A diagnosis of PEComa was made and an uncomplicated middle pancreatectomy was performed. Our case and review of the literature demonstrates that EUS-FNA complemented with tissue cell block increases cellular yield, improved preoperative diagnostic accuracy, and may assist the surgeon in planning conservative surgical management. Diagn. Cytopathol. 2017;45:59-65. © 2016 Wiley Periodicals, Inc.

Management of Patients With Pancreatic Cysts: Analysis of Possible False-Negative Cases of Malignancy.

GOALS: To examine the utility of integrated molecular pathology (IMP) in managing surveillance of pancreatic cysts based on outcomes and analysis of false negatives (FNs) from a previously published cohort (n=492). BACKGROUND: In endoscopic ultrasound with fine-needle aspiration (EUS-FNA) of cyst fluid lacking malignant cytology, IMP demonstrated better risk stratification for malignancy at approximately 3 years' follow-up than International Consensus Guideline (Fukuoka) 2012 management recommendations in such cases. STUDY: Patient outcomes and clinical features of Fukuoka and IMP FN cases were reviewed. Practical guidance for appropriate surveillance intervals and surgery decisions using IMP were derived from follow-up data, considering EUS-FNA sampling limitations and high-risk clinical circumstances observed. Surveillance intervals for patients based on IMP predictive value were compared with those of Fukuoka. RESULTS: Outcomes at follow-up for IMP low-risk diagnoses supported surveillance every 2 to 3 years, independent of cyst size, when EUS-FNA sampling limitations or high-risk clinical circumstances were absent. In 10 of 11 patients with FN IMP diagnoses (2% of cohort), EUS-FNA sampling limitations existed; Fukuoka identified high risk in 9 of 11 cases. In 4 of 6 FN cases by Fukuoka (1% of cohort), IMP identified high risk. Overall, 55% of cases had possible sampling limitations and 37% had high-risk clinical circumstances. Outcomes support more cautious management in such cases when using IMP. CONCLUSIONS: Adjunct use of IMP can provide evidence for relaxed surveillance of patients with benign cysts that meet Fukuoka criteria for closer observation or surgery. Although infrequent, FN results with IMP can be associated with EUS-FNA sampling limitations or high-risk clinical circumstances.

Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts.

BACKGROUND AND STUDY AIMS: Current diagnostic testing is inadequate to determine the malignant potential of pancreatic cysts, resulting in overcautious patient management. Integrated molecular pathology (IMP) testing combines molecular analysis with first-line test results (cytology, imaging, and fluid chemistry) to assess the malignant potential of pancreatic cysts. This multicenter study aimed to determine the diagnostic accuracy of IMP for pancreatic adenocarcinoma, and the utility of IMP testing under current guideline recommendations for managing pancreatic cysts. PATIENTS AND METHODS: Patients who had undergone previous IMP testing as prescribed by their physician and for whom clinical outcomes were available from retrospective record review were included (n = 492). Performance was determined by correlation between clinical outcome and previous IMP diagnosis ("benign"/"statistically indolent" vs. "statistically higher risk [SHR]"/ "aggressive") or an International Consensus Guideline (Sendai 2012) criteria model for "surveillance" vs. "surgery." The Cox proportional hazards model determined hazard ratios for malignancy. RESULTS: Benign and statistically indolent IMP diagnoses had a 97 % probability of benign follow-up for up to 7 years and 8 months from initial IMP testing. SHR and aggressive diagnoses had relative hazard ratios for malignancy of 30.8 and 76.3, respectively (both P < 0.0001). Sendai surveillance criteria had a 97 % probability of benign follow-up for up to 7 years and 8 months, but for surgical criteria the hazard ratio was only 9.0 (P < 0.0001). In patients who met Sendai surgical criteria, benign and statistically indolent IMP diagnoses had a > 93 % probability of benign follow-up, with relative hazard ratios for SHR and aggressive IMP diagnoses of 16.1 and 50.2, respectively (both P < 0.0001). CONCLUSION: IMP more accurately determined the malignant potential of pancreatic cysts than a Sendai 2012 guideline management criteria model. IMP may improve patient management by justifying more relaxed observation in patients meeting Sendai surveillance criteria. IMP can more accurately differentiate between the need for surveillance or surgery in patients meeting Sendai surgical criteria.

Achilles tenotomy as an office procedure: safety and efficacy as part of the Ponseti serial casting protocol for clubfoot.

BACKGROUND: Ponseti demonstrated the correction of clubfoot in infants using manipulation followed by the application of well-molded long-leg plaster casts. Percutaneous Achilles tenotomy was recommended to correct residual equinus contracture in approximately 80% of cases. In the current study, we evaluated the safety of this practice for the treatment of clubfoot when performed as an "office procedure" without sedation or general anesthesia during the final stage of the serial casting protocol. PATIENTS AND METHODS: We retrospectively collected data regarding babies who underwent serial manipulation and casting according to the Ponseti protocol for the treatment of clubfoot. All babies managed in the outpatient clinic between 2006 and 2010 were included. Tenotomy was indicated when the forefoot was completely corrected and if the hind-foot showed rigid equinus. Tenotomy was performed by a single scalpel stab in the outpatient clinic, using topical and local anesthesia (without general anesthesia or sedation). The cast was then applied and kept on for 3 weeks. Babies were discharged home after 1 hour of supervision. Surgical reports regarding Achilles tenotomy were reviewed, and data were collected from postoperative notes. We specifically looked for perioperative complications, recovery unit notes, and hospital readmission. RESULTS: Fifty-six babies (83 feet) were included in the current study. There were 40 males and 16 females, and 27 of them had bilateral clubfoot. Three babies (0.5%) had complex (syndrome-related) clubfoot; familial risk was known in 6 (11%) babies. Forty-one (73%) babies were indicated for Achilles tenotomy. Tenotomy was performed after an average of 5 casts (range, 3 to 9). No adverse events were related to local anesthesia and/or the procedure itself, and there was no delay in discharge in any of the operated babies. One baby was evaluated in the emergency room 3 days after the procedure because of (unfounded) parental concern of swelling inside the cast. All other babies had an uneventful course. Retenotomy was performed in 7 babies (12 feet); 2 of them (4 feet) had complex clubfoot. All of these babies (ie, their parents), except 1, had moderate to poor compliance with the treatment protocol. CONCLUSIONS: Tenotomy as an office procedure using topical and local anesthesia is a safe procedure. It does not incur a substantial rate of readmission to the emergency room, either because of parental concern or because of actual complications. The need for retenotomy is related to a low compliance with the treatment protocol. LEVEL OF EVIDENCE: Level II.

Necrotizing upper limb fasciitis in a newborn: an uncommon life-threatening event.

Necrotizing fasciitis is an uncommon but life-threatening infection in the pediatric population. It is rarely reported in neonates. In these rare cases, the reported origin of infection was the umbilical cord stump, infection due to circumcision, and similar lesions. We hereby report a 3-week-old neonate sustaining necrotizing fasciitis without detectable origin of infection. We describe the clinical course of her illness, the diagnostic process, and eventual surgical intervention. We discuss the importance of awareness to this potentially lethal infectious disease and the need for urgent use of certain imaging modalities and aggressive surgical approach.

Massive allograft of the tibia for a child with McCune-Albright syndrome: case presentation and surgical intervention.

We hereby present a case of massive allografting of the tibia in a 9-year-old girl with McCune-Albright syndrome. Total replacement of the diaphysis and preservation of growth plates on both ends of the tibia was performed. After 5 years of follow-up, the graft is still intact and growth plates are active. We discuss the current knowledge about this syndrome, intervention modalities, as well as advantages and disadvantages of massive allografting.

Kingella kingae infections in children.

Kingella kingae is a beta-hemolytic gram-negative bacillus. It was first described in the 1960's by EO King and has been reported as a cause of osteo-articular pediatric infections since the early 1980's. We performed a retrospective review of all pediatric cases of invasive K. kingae infection between 1997 and 2002, in order to define the incidence, clinical presentation and outcome of invasive K. kingae infections in a pediatric population. During the study period, a total of 24 pediatric patients with K. kingae infection were identified. There were 15 blood culture isolates of K. kingae, out of a total of 1151 (1.3%) positive blood cultures, and 9 synovial fluid culture isolates out of a total of 76 (11.8%) positive synovial fluids. Fifteen patients had osteo-articular infections and 9 had primary bacteremia without osteo-articular infection. Outcome was favorable in all cases and only in 2 patients with knee joint infection was surgical intervention performed, by means of formal knee arthrotomy. All patients recovered uneventfully, in 7 cases without any intervention and in the others with intravenous or oral antibiotic. In conclusion, invasive K. kingae infection is not uncommon in Israel. It usually has a mild course and thus is not always detected and treated. As K. kingae grows best in blood culture broth, blood and joint fluid should always be inoculated into blood culture bottles in suspected cases. This bacterium is highly sensitive to betalactame antibiotics and infection resolves quickly with antibiotic treatment. Surgical intervention for osteo-articular infection is seldom indicated.