Impact of COVID-19 infection and vaccination in pancreatobiliary IgG4-related disease patients: An international multicenter study.

BACKGROUND AND AIM: Dedicated studies evaluating the impact of COVID-19 on outcomes of pancreatobiliary IgG4 related disease (IgG4-RD) patients are scarce. Whether COVID-19 infection or vaccination would trigger IgG4-RD exacerbation remains unknown. METHODS: Pancreatobiliary IgG4-RD patients ≥ 18 years old with active follow-up since January 2020 from nine referral centers in Asia, Europe, and North America were included in this multicenter retrospective study. Outcome measures include incidence and severity of COVID-19 infection, IgG4-RD disease activity and treatment status, interruption of indicated IgG4-RD treatment. Prospective data on COVID-19 vaccination status and new COVID-19 infection during the Omicron outbreak were also retrieved in the Hong Kong cohort. RESULTS: Of the 124 pancreatobiliary IgG4-RD patients, 25.0% had active IgG4-RD, 71.0% were on immunosuppressive therapies and 80.6% had ≥ 1 risk factor for severe COVID. In 2020 (pre-vaccination period), two patients (1.6%) had COVID-19 infection (one requiring ICU admission), and 7.2% of patients had interruptions in indicated immunosuppressive treatment for IgG4-RD. Despite a high vaccination rate (85.0%), COVID-19 infection rate has increased to 20.0% during Omicron outbreak in the Hong Kong cohort. A trend towards higher COVID-19 infection rate was noted in the non-fully vaccinated/unvaccinated group (17.6% vs 33.3%, P = 0.376). No IgG4-RD exacerbation following COVID-19 vaccination or infection was observed. CONCLUSION: While a low COVID-19 infection rate with no mortality was observed in pancreatobiliary IgG4-RD patients in the pre-vaccination period of COVID-19, infection rate has increased during the Omicron outbreak despite a high vaccination rate. No IgG4-RD exacerbation after COVID-19 infection or vaccination was observed.

International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.

BACKGROUND AND AIMS: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. METHODS: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. RESULTS: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). CONCLUSIONS: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).

Endoscopic management of post-surgical GI wall defects with the overstitch endosuturing system: a single-center experience.

BACKGROUND AND AIMS: Post-GI surgical wall defects are frequent and life-threatening complications, with limited literature regarding current treatment. This case series aims to assess the safety, feasibility, and outcomes of endoluminal therapy with the overstitch endoscopic suturing system (Apollo Endosurgery Inc, Austin). MATERIALS AND METHODS: All patients who underwent endoscopic suturing for post-surgical wall defect management at IRCCS-ISMETT Palermo from October 2017 until January 2019 were retrospectively enrolled. Stratification therapy was applied according to the clinical scenario, time from surgery to endoscopic intervention, and structural condition of the wall defect layers (tissue status and suture feasibility). The therapeutic endoscopic strategy was divided into three groups (A: pure endoscopic direct suture; B: combined therapy with endoscopic direct suture + FC-SEMS placement + anchoring; C: FC-SEMS placement + anchoring). Success was considered the resolution of symptoms and the presence of a regular intestinal transit after a period of 4-6 weeks. RESULTS: Twenty (20) patients (male/female 7/13; mean age 54 ± 13.43 years) were included in the study (group A: 9 patients, group B: 7 patients, group C: 4 patients). The types of operative procedures were bariatric (9/20), post-tracheostomy (3/20), post-operative GI surgery (8/20). The post-surgical defects were predominantly intermediate and chronic (24-72 h: 1/20; 3-30 days: 13/20; > 30 days: 6/20). The overall clinical success was 80% (17/20 patients), with a success of 94% (16/17 patients) when excluding the three cases of tracheo-esophageal fistula. No evidence of migration was detected. The only complication was short stenosis of the distal esophagus, present in 4 patients (19%) and successfully treated with a novel lumen-apposing metal stent. CONCLUSIONS: In our experience, considering the absence of clear guidelines, the endoluminal approach with the overstich endoscopic suturing system is a valid alternative to conventional therapy, offering mini-invasiveness, and presenting promising opportunities in terms of technical feasibility and clinical efficacy.

Sequential multistenting protocol in biliary stenosis after liver transplantation: a prospective analysis.

BACKGROUND: Biliary complications are a serious source of morbidity after orthotopic and living-related liver transplantation. Endoscopic retrograde cholangiography (ERC) is the gold standard for patients with duct-to-duct anastomosis because it allows a direct approach for interventional procedures. A retrospective study showed results of a sequential multistenting protocol, without stent removal/exchange, with promising results. We conducted a prospective analysis to assess the clinical success, recurrence rate, and adverse event rate related to this protocol. METHODS: From May 2012 to April 2018, all consecutive patients with a diagnosis of anastomotic stenosis following liver transplantation were enrolled in the study, and were followed for a period of at least 6 months after the last ERC. During the first ERC, a maximum number of plastic stents (10 Fr) were placed. In subsequent ERCs, scheduled every 3 months up to a maximum of 1 year, additional stents were inserted, as many as possible, without removing the previously placed stents. RESULTS: From May 2012 to May 2018, 87 patients were included in the study and treated with a sequential multistenting protocol. The mean number of stents placed was 3.7 (SD 1.0). Clinical success (stricture resolution and normalization of cholestasis) was achieved in 86 patients (98.9 %). Seven patients (8.0 %) developed complications. Recurrence was recorded in seven patients (8.0 %) after a mean of 992.7 days (SD 622.1). CONCLUSIONS: This study represents the first prospective demonstration of the efficacy and safety of a sequential multistenting protocol. A key limitation of the study is the lack of a comparative group treated according to the traditional stent exchange approach.

Endo-therapies for biliary duct-to-duct anastomotic stricture after liver transplantation: Outcomes of a nationwide survey.

BACKGROUND: The most appropriate endo-therapeutic approach to biliary anastomotic strictures is yet to be defined. AIM: To retrospectively report on the endo-therapy of duct-to-duct anastomotic strictures during 2013 in Italy. METHODS: Data were collected from 16 Endoscopy Units at the Italian Liver Transplantation Centers (BASALT study group). RESULTS: Complete endo-therapy and follow-up data are available for 181 patients: 101 treated with plastic multistenting, 26 with fully covered self-expandable metal stenting and 54 with single stenting. Radiological success was achieved for 145 patients (80%), that is, 88% of plastic multistenting, 88% of self-expandable metal stenting and 61% of single stenting (P < 0.001 vs plastic multistenting; P < 0.05 vs self-expandable metal stenting). After first-line endo-therapy failure, the patients underwent a second-line endo-therapy with plastic multistenting for 25%, fully covered self-expandable metal stenting for 53% and single stenting for 22% of cases, and radiological success was achieved for 84%, that is, 100%, 85% and 63% with plastic multistenting, self-expandable metal stenting and single stenting (P < 0.05 vs plastic multistenting or self-expandable metal stenting) respectively. Procedure-related complications occurred in 7.8% of endoscopic retrograde cholangiopancreatographies. Overall, clinical success was achieved in 87% of patients after a median follow-up of 25 months. CONCLUSION: Plastic multistenting is confirmed as the preferred first-line treatment, while fully covered self-expandable metal stenting as rescue option for biliary anastomotic strictures. Single stenting has sub-optimal results and should be abandoned.

Underwater colorectal EMR: remodeling endoscopic mucosal resection.

BACKGROUND: Underwater EMR (UEMR) has been reported as a new technique for the removal of large sessile colorectal polyps without need for submucosal injection. OBJECTIVE: To evaluate (1) outcomes of UEMR, (2) whether UEMR can be easily performed by an endoscopist skilled in traditional EMR without specific dedicated training in UEMR, and (3) whether EUS is required before UEMR. DESIGN: Prospective, observational study. SETTING: Single, tertiary-care referral center. INTERVENTION: Underwater EMR. MAIN OUTCOME MEASUREMENTS: Complete resection and adverse events. RESULTS: A total of 72 consecutive patients underwent UEMR of 81 sessile colorectal polyps. EUS was performed before UEMR in 9 cases (11.1%) with a suspicious mucosal/vascular pattern. The mean polyp size was 18.7 mm (range 10-50 mm); the mean UEMR time was 11.8 minutes. Fifty-five polyps (68%) were removed en bloc, and 26 (32%) were removed with a piecemeal technique. Histopathology consisted of tubular adenomas (25.9%), tubulovillous adenomas (5%), adenomas with high-grade dysplasia (42%), serrated polyps (4.9%), carcinoma in situ (13.6%), and hyperplastic polyps (8.6%). Surveillance colonoscopy was scheduled at 3 months. Complete resection was successful in all patients. No adverse events or recurrence was recorded in any of the patients. LIMITATIONS: Limited follow-up; single-center, uncontrolled study. CONCLUSION: Interventional endoscopists skilled in conventional EMR performed UEMR without specific dedicated training. EUS may not be required for lesions with no invasive features on high-definition narrow-band imaging. UEMR appears to be an effective and safe alternative to traditional EMR and could eventually improve the way in which we can effectively and safely treat colorectal lesions.