Risk of Covert Submucosal Cancer in Patients With Granular Mixed Laterally Spreading Tumors.

BACKGROUND AND AIMS: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. METHODS: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. RESULTS: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. CONCLUSIONS: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.

Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes.

INTRODUCTION: Multiple therapeutic modalities including surgery and rigid and flexible endoscopy have been adopted to manage Zenker's diverticulum (ZD). Minimally invasive flexible endoscopic septotomy (FES) techniques have been increasingly favored over the past 20 years; however, long-term data are still scanty. The aim of this study is to evaluate early and long-term outcomes of FES for naive ZD in a single-center setting. METHODS: From 2010 to 2017, ZD patients treated with FES were included in a prospectively maintained database (NCT03948438). Those who had already been treated surgically or endoscopically were excluded from the analysis. The Dakkak and Bennett dysphagia scale was used to rate the dysphagia. Persistent complete or near-complete resolution of symptoms (Dakkak and Bennett 0 or 1) was defined as clinical success. Postprocedural adverse events were reported according to ASGE lexicon. RESULTS: Overall, 256 consecutive patients were treated. Mean pouch size was 29.8 ± 11.3 mm. The procedure was successfully completed in all scheduled patients, with an early clinical success of 96.1%. Adverse events occurred in 3.5% (9/256) of patients. Eight of them were mild/moderate with no fatal events, whereas one patient required surgery. Recurrences occurred in 31.3% (80/256) of treated patients after a mean time of 9 ± 3 months and 95% of recurrences were treated by a second FES. At an average follow-up of 5.5 years, 95.3% of patients were asymptomatic after a mean number of 1.3 procedures. DISCUSSION: FES is a safe and effective treatment modality for patients with ZD. Recurrence rate is significant; however, endoscopic reintervention is associated with long-term relief of dysphagia.

Coronavirus (COVID-19) outbreak: what the department of endoscopy should know.

Italy recorded its first case of confirmed acute respiratory illness because of coronavirus on February 18, 2020, soon after the initial reports in China. Since that time, Italy and nations throughout the world have adopted very stringent and severe measures to protect populations from spread of infection. Despite these measures, the number of infected people is growing exponentially, with a significant number of patients developing acute respiratory insufficiency. Endoscopy departments face significant risk for diffusion of respiratory diseases that can be spread via an airborne route, including aspiration of oral and fecal material via endoscopes. The purpose of this article is to discuss the measures, with specific focus on personal protection equipment and dress code modalities, implemented in our hospital to prevent further dissemination of COVID-19 infection.

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience.

BACKGROUND/AIMS: The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. METHODS: Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. RESULTS: A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients). CONCLUSION: The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome.

Natural history and management of refractory benign esophageal strictures.

BACKGROUND AND AIMS: The natural history of refractory benign esophageal strictures (RBES) is unclear, and surgery or percutaneous endoscopic gastrostomy (PEG) may be the only viable long-term options. The aim of the present study was to assess the long-term outcomes of patients with RBES. METHODS: Clinical data of consecutive patients with RBES treated in the previous 15 years in 2 tertiary-care referral academic centers with specialized interest in esophageal stricture management were retrospectively analyzed. RBES was defined as the persistence and/or recurrence of dysphagia despite at least 5 dilation sessions and/or cycles with dilation to at least 14 mm. Information regarding the use of dilation or stents and the dysphagia-free period between subsequent interventions and adverse events was collected. Clinical success was defined as no need for endoscopic interventions for at least 6 months; unfavorable outcomes were defined as the need for endoscopic treatment at the end of follow-up, surgery, or percutaneous endoscopic gastrostomy (PEG). Predictors of unfavorable outcomes were assessed by multivariate analysis. A linear mixed-effect model was used to measure dysphagia-free period changes over time. RESULTS: Overall, 70 patients with RBES (46 male; mean age 60 years) were followed for a mean of 43.9 months (range 3.7-157 months). Caustic, postradiotherapy, surgical, mixed, and postinflammatory etiology accounted for 10%, 14.3%, 31.4%, 40%, and 4.3% of causes, respectively. All patients underwent sequential sessions of pneumatic or bougie dilation, with a median of 15.5 dilation sessions per patient. Self-expandable metal stents (SEMSs) and biodegradable stents were placed in 18 (25.7%) and 14 (20%) patients, respectively. RBES resolution was achieved in only 22 of 70 (31.4%) patients. Two deaths (3%) were related to RBES. The success rate was lower in those who also were treated with endoprosthetics (odds ratio [OR] 3.7; 95% confidence interval [CI], 1.01-18.0). The mean dysphagia-free period was 3.3 months (95% CI, 2.4-4.1) for patients treated with dilation and 2.4 months (95% CI, 1.2-3.6) for those treated with stents (P = .062). Over time, the total dysphagia-free period increased at a rate of 4.1 days (95% CI, 1.7-6.4) per dilation. There was no difference in the rate of change across groups defined by sex (P = .976), age (P = .633), or endoscopic treatment (P = .267). CONCLUSIONS: Our multicenter series showed a disappointing long-term outcome for RBES, with only 1 of 3 achieving clinical resolution. The dysphagia-free period was relatively short, affecting the quality of life. Endoprosthetics did not appear to affect the natural history of RBES.

Feasibility and safety of a new dedicated biliary stent for EUS-guided hepaticogastrostomy: The FIT study (with video).

Background and Objectives: EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems. Methods: This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed. Results: Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred. Conclusion: EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.

Pilot study on a new endoscopic platform for colorectal endoscopic submucosal dissection.

Background: The endoscopic submucosal dissection (ESD) is a technically demanding and time-consuming procedure, with an increased risk of adverse events compared to standard endoscopic resection techniques. The main difficulties are related to the instability of the operating field and to the loss of traction. We aimed to evaluate in a pilot trial a new endoscopic platform [tissue retractor system (TRS); ORISE, Boston scientific Co., Marlborough, MA, USA], designed to stabilize the intraluminal space, and to provide tissue retraction and counter traction. Method: We prospectively enrolled all consecutive patients who underwent an ESD for sigmoid/rectal lesions. The primary outcome was the rate of technical feasibility. Further technical aspects such as en-bloc and R0 resection rate, number of graspers used, circumferential incision time, TRS assemblage time, submucosal dissection time, and submucosal dissection speed were provided. Clinical outcomes (recurrence rate and adverse events) were recorded as well. Results: In all, 10 patients (M/F 4/6, age: 70.4 ± 11.0 years old) were enrolled. Eight out of 10 lesions were located in the rectum. Average lesion size was 31.2 ± 2.7 mm, and mean lesion area was 1628.88 ± 205.3 mm2. The two sigmoid lesions were removed through standard ESD, because the platform assemblage failed after several attempts. All rectal lesions were removed in an en-bloc fashion. R0 resection was achieved in 7/8 (87.5%) patients in an average procedure time of 60.5 ± 23.3 min. None of the patients developed neither intraprocedural nor postprocedural adverse events. Conclusion: TRS-assisted ESD is a feasible option when used in the rectum, with promising result in terms of efficacy and safety outcomes. Nevertheless, our pilot study underlines few technical limitations of the present platform that need to be overcome before the system could be widely and routinely used.

Endoscopic submucosal dissection for colorectal neoplasia: outcomes and predictors of recurrence.

Background and study aims The role of endoscopic submucosal dissection (ESD) for colorectal lesions in Western communities is unclear and its adoption is still limited. The aim of this study is to assess the long-term outcomes of a large cohort of patients treated with colorectal ESD in a tertiary Western center. Patients and methods A retrospective analysis was conducted on patients treated by ESD for superficial colorectal lesions between February 2011 and November 2019. The primary outcome was the recurrence rate. Secondary outcomes were en-bloc and R0 resection rates, procedural time, adverse events (AEs), and need for surgery. The curative resection rate was assessed for submucosal invasive lesions. Results A total of 327 consecutive patients, median age 69 years (IQR 60-76); 201 men (61.5 %) were included in the analysis. Of the lesions, 90.8 % were resected in an en-bloc fashion. The rate of R0 resection was 83.1 % (217/261) and 44.0 % (29/66) for standard and hybrid ESD techniques, respectively. Submucosal invasion and piecemeal resection independently predicted R1 resections. A total of 18(5.5 %) intra-procedural AEs (perforation:11, bleeding:7) and 12(3.7 %) post-procedural AEs occurred (perforation:2, bleeding: 10). Eighteen adenoma recurrences per 1,000 person-years (15cases, 5.6 %) were detected after a median follow-up time of 36 months. All recurrences were detected within 12 months. No carcinoma recurrences were observed. R1 resection status and intra-procedural AEs independently predicted recurrences with seven vs 150 recurrences per 1,000 person-years in the R0 vs R1 group, respectively. Conclusions Colorectal ESD is a safe and effective option for managing superficial colorectal neoplasia in a Western setting, with short and long-terms outcomes comparable to Eastern studies. En-bloc R0 resection and absence of intra-procedural AEs are associated with reduced risk of recurrence.

Flexible endoscopic treatment for Zenker's diverticulum: from the lumen to the third space.

Zenker's diverticulum (ZD) is a rare outpouching of the esophageal mucosa herniating posteriorly through Killian's triangle. Treatments of ZD aim to dissect the cricopharyngeal muscle to remove the underlying dysfunctional condition. In the last decade, a septotomy performed utilizing a flexible endoscope has been reported as a safe and effective alternative to both open surgery and rigid endoscopic diverticulotomy. More recently, Li et al described a novel endoscopic technique to treat ZD, named "submucosal tunneling endoscopic septum division", inspired by the peroral endoscopic myotomy (POEM) procedure developed for achalasia. Subsequently, the term Z-POEM was introduced and has become the most frequently used acronym to define the tunneling technique for ZD. This article describes the flexible therapeutic endoscopic strategies for treating ZD, including the novel third space approach, which seems to show promising potential in terms of clinical efficacy and safety.

Cost analysis and outcome of endoscopic submucosal dissection for colorectal lesions in an outpatient setting.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD), a minimally invasive treatment for early gastrointestinal (GI) cancer, is considered challenging and risky in the colorectum. As such, most patients undergoing ESD are hospitalized due to the perceived increased risk of adverse events. The aim of this study was to compare the costs, safety and efficacy of colorectal-ESD in an outpatient vs inpatient setting in a tertiary level center. METHODS: This is a retrospective study on consecutive patients admitted for colorectal-ESD. Patients were divided into outpatients (Group-A, same-day discharge), and inpatients (Group-B, admitted for at least one night). Data on overall costs, outcomes and adverse events were assessed for each group. RESULTS: A total of 136 patients were considered. Fourteen were excluded because ESD was not performed due to intraprocedural suspicion of invasive cancer. Eighty-three patients were treated as outpatients (Group-A, 68%) and 39 (Group-B, 32%) were hospitalized. R0-rate was 90.4% in Group-A and 89.7% in Group-B(P = 0.98). One perforation occurred in Group-A (1.2%) and 2 in Group-B(5.1%, P = 0.2). Mean Length of stay (LOS) was 1 day for outpatients and 3.3 days for inpatients. Management of Group-A as outpatients produced a cost savings of 941€ on average per patient. CONCLUSIONS: Outpatient colorectal-ESD is a feasible, cost-effective strategy to manage superficial colorectal tumors with outcomes comparable to inpatient colorectal-ESD. By using proper selection criteria, outpatient ESD could be considered the first-line approach for most patients.

Endoscopic Management of Benign Esophageal Ruptures and Leaks.

OPINION STATEMENT: Esophageal leaks (EL) and ruptures (ER) are rare conditions associated with a high risk of mortality and morbidity. Historically, EL and ER have been surgically treated, but current treatment options also include conservative management and endoscopy. Over the last decades, interventional endoscopy has evolved as an effective and less invasive alternative to primary surgery in these cases. A variety of techniques are currently available to re-establish the continuity of the digestive tract, prevent or treat infection related to the leak/rupture, prevent further contamination, drain potential collections, and provide nutritional support. Endoscopic options include clips, both through the scope (TTS) and over the scope (OTS), stent placement, vacuum therapy, tissue adhesive, and endoscopic suturing techniques. Theoretically, all of these can be used alone or with a multimodality approach. Endoscopic therapy should be combined with medical therapy but also with percutaneous drainage of collections, where present. There is robust evidence suggesting that this change of therapeutic paradigm in the form of endoscopic therapy is associated with improved outcome, better quality of life, and shortened length of hospital stay. Moreover, recent European guidelines on endoscopic management of iatrogenic perforation have strengthened and to some degree regulated and redefined the role of endoscopy in the management of conditions where there is a breach in the continuity of the GI wall. Certainly, due to the complexity of these conditions and the variety of available treatment options, a multidisciplinary approach is strongly recommended, with close clinical monitoring (by endoscopists, surgeons, and intensive care physicians) and special attention to signs of sepsis, which can lead to the need for urgent surgical management. This review article will critically discuss the literature regarding endoscopic modalities for esophageal leak and perforation management and attempt to place them in perspective for the physician.

Endo-sponge therapy for management of anastomotic leakages after colorectal surgery: A case series and review of literature.

BACKGROUND: Endo-sponge treatment is a novel approach to manage selected patients with anastomotic leakage following colorectal surgery. However, the available data are still scanty. AIMS: To evaluate the efficacy and safety of the endo-sponge therapy in a large series, and to perform a review of the current evidence concerning such a treatment. METHODS: Consecutive patients diagnosed with partial colonic anastomotic leakage managed with endo-sponge placement were enrolled. The endo-sponge system was changed every 48-72 h as outpatient, until to cavity closure. Literature review was performed for pooled-data analysis. RESULTS: Twenty-five patients were enrolled, including 13 (52%) with diverting ileostomy. Following endo-sponge applications (median sessions: 9, range: 1-39; median treatment duration: 4 weeks, range: 1-32), a complete healing was achieved in 22 (88%) patients. Three (12%) patients developed a major complication (1 uretheric fistula, 1 ileal fistula, and 1 pararectal abscess), all successfully treated by surgery. Ileostomy closure was achieved in 11 (84.6%) patients. No mortality related to the procedure was observed. Overall, 174 patients treated with endo-sponge were reported in literature. By considering data of the larger 7 studies, a complete healing of presacral cavity was achieved in 131 (94.3%) out of 149 patients. CONCLUSIONS: Our relatively large series of patients confirmed the efficacy, tolerability, and an acceptably low complication rate of endo-sponge therapy for colorectal anastomosis leakage treatment.

Timing of antibiotic prophylaxis in acute pancreatitis: a controlled randomized study with meropenem.

OBJECTIVES: Antibiotic prophylaxis improves the outcome of acute pancreatitis. Since bacterial translocation from the gut occurs in the first h of disease, early therapy is likely to achieve the maximal effect. The study compares early antibiotic treatment with treatment started after the demonstration of pancreatic necrosis. METHODS: Two hundred fifteen patients with pancreatitis were randomized to either group A (N=108), who started antibiotic therapy (meropenem 500 mg t.i.d.) at admission, or group B (N=107), who received antibiotics after the demonstration of necrosis at computed tomography (CT). CT was performed in both groups after at least 48 hr of hospitalization. The clinical course of disease was compared in the two groups. RESULTS: Thirty patients in group A and 29 in B showed necrosis on CT. The two groups were similar in demographics and characteristics of disease. Antibiotic treatment was started after 4.56+/-1.2 days from hospitalization in group B and after 1.07+/-0.6 days in A. Pancreatic infection occurred in four patients in group A (13.3%) and in nine in B (31%) (p=0.1). Extrapancreatic infection occurred in 16.6% of patients in group A and in 44.8% in B (p<0.05). Need for surgery and length of hospitalization were also higher in group B. Mortality rates were similar in the two groups, but, 3 of 4 patients with infected necrosis in group A and only 2 of 9 in group B died. CONCLUSIONS: Early antibiotic treatment is associated with a significant improvement in the prognosis of necrotizing acute pancreatitis (AP), because of a reduction in the occurrence of septic complications.