Technical failure during Colorectal Endoscopic Full Thickness Resection: The "through thick and thin" Study.

BACKGROUND: Endoscopic full-thickness resection (EFTR) is an effective and safe technique for non-lifting colorectal lesions. Technical issues or failures with full-thickness resection device (FTRD) system are reported but there are no data about their details. The aim of our study was to quantify and classify FTRD technical failures. PATIENTS AND METHODS: We performed a retrospective study involving 17 Italian centres with experience in advanced resection techniques and OVESCO devices. Each centre shared and classified all the consecutive failures prospectively collected during colorectal EFTR by using FTRD from 2018 to 2022. Primary outcome was technical failure rate and classification; secondary outcomes included management, clinical success, and complications' assessment in this population. RESULTS: Included lesions were mainly recurrent (52%), with mean dimension of 18.4 (± 7.5) mm. Among 750 EFTRs, failures occurred in 77 patients (35 F, mean age 68.9 ±8.9 years). A classification was proposed in type I snare uncutting (53.2%), type II clip misdeployment (31.2%) and type III cap misplacement (15.6%). Among endoscopic treatment completed, rescue EMR was performed in 57 patients (79%), allowing en-bloc and R0 resection in 71% and 64% cases, respectively. Overall adverse events rate was 27.3%. Pooled estimates for the rate of failure, complications and rescue endoscopic therapy were similar between low- and high-volume centres (p=0.08, p = 0.702 and p= 0.713). CONCLUSIONS: Colorectal EFTR with FTRD is a challenging technique with a not negligible rate of technical failure and complications. Experience in rescue resection techniques and multidisciplinary management are mandatory in this setting.

Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study.

BACKGROUND AND AIM: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications. METHODS: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications. RESULTS: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal. CONCLUSION: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

Novel Hemostatic Gel As Rescue Therapy for Postsphincterotomy Bleeding Refractory to Self-Expanding Metallic Stent Placement.

Endoscopic sphincterotomy (ES) is commonly performed during endoscopic retrograde cholangiopancreatography, and bleeding is a severe adverse event. PuraStat is a peptide developed as a hemostatic agent for endoscopy. We report its use as a hemostatic strategy in post-ES bleeding refractory to combined hemostasis. A patient with choledocholithiasis underwent endoscopic retrograde cholangiopancreatography for stone removal. After the ES, severe bleeding refractory to the injection of diluted epinephrine around the bleeding source and metal stent placement occurred. Hemostasis was achieved with the application of the hemostatic gel. We reported the use of novel self-assembling hemostatic gel as an effective therapeutic tool for post-ES refractory bleeding.

The high rate of spontaneous migration of small size common bile duct stones may allow a significant reduction in unnecessary ERCP and related complications: results of a retrospective, multicenter study.

INTRODUCTION: Common bile duct stones (CBDS) can spontaneously migrate through the duodenal papilla. In this case, ERCP could be unnecessary and a significant rate of complications could be avoided. In this study, we aim at retrospectively evaluating the rate of spontaneous stone passage in patients with an imaging diagnosis of CBDS and at analysing the factors associated to spontaneous stone migration. METHODS: We conducted a retrospective multi-centre analysis of patients undergoing ERCP for CBDS in a 12-month period. 1016 patients with CBDS were analysed. In all patients CBDS was diagnosed with adequate imaging methods performed prior to ERCP. ERCPs with failed biliary cannulation were excluded. Data regarding patients' characteristics, imaging findings and ERCP procedure were analysed. RESULTS: 1016 patients with CBDS undergoing ERCP were analysed (male sex 43.3%; mean age 69.9 ± 16.5 years). Diagnosis of CBDS was obtained by EUS in 415 patients (40.8%), MR in 343 (33.8%), CT in 220 (21.7%), and US in 38 (3.7%). No stones were found at ERCP in 179 patients (17.6%), in 14 (6.2%) when ERCP was performed within 6 h from imaging study, in 114 (18.5%) between 7 h and 7 days, in 32 (24.6%) between 8 and 29 days, and in 19 (43.2%) after 30 days. The rate of unnecessary ERCP occurred significantly more frequently in patients in whom imaging methods demonstrated either sludge or ≤ 5 mm CBDS (29.9 vs. 8.3%; p < 0.001). DISCUSSION: Spontaneous migration of small CBDS is a frequent event, and ≤ 5 mm size and a delay in ERCP > 7 days represent predictive factors for it. We suggest that CBDS ≤ 5 mm should not undergo immediate removal and this fact would allow reducing the rate of unnecessary ERCP with their related complications. Prospective studies are needed to confirm these results and demonstrate the safety of a conservative management in this setting.

A prospective study on quality in endoscopic retrograde cholangiopancreatography (ERCP): trend in Italy from the REQUEST study.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure with a relatively high rate of adverse events. Data on training of operators and fulfillment of quality indicators in Italy are scarce. The goal of this study was to assess the overall quality of ERCP in Italy compared to international standards. Patients and methods This was a prospective, observational study from different Italian centers performing ERCP. Operators answered a questionnaire, then recorded data on ERCPs over a 1-to 3-month period. Results Nineteen Italian centers participated in the study. The most common concern of operators about training was the lack of structured programs. Seven/19 centers routinely used conscious sedation for ERCP. Forty-one experienced operators and 21 trainees performed 766 ERCPs: a successful deep biliary cannulation in native-papilla patients was achieved in 95.1 % of cases; the post-ERCP pancreatitis (PEP) rate was 5.4 % in native-papilla patients; cholangitis rate was 1.0 %; bleeding and perforation occurred in 2.7 % and 0.4 % of the patients, respectively. Conclusions This study revealed that, overall, ERCP is performed in the participating Italian centers meeting good quality standards, but structured training and sedation practice are still subpar. The bleeding and perforation rate slightly exceeded the American Society of Gastrointestinal Endoscopy indicator targets but they are comparable to the reported rates from other international surveys.

Endoscopic Application of Purastat® in the Treatment of Solitary Rectal Ulcer Syndrome.

A 49-years-old woman with a recent history of tenesmus, constipation, abdominal and rectal pain referred to our Unit. There was no previous history of rectal bleeding or a family history of gastrointestinal diseases. Laboratory tests showed haemoglobin 10.9 g/dl, MCV 72fl, ferritin 18 U/l. Physical examination was normal. The patient underwent a colonoscopy which identified a single ulcer of 2.5 cm of diameter without bleeding signs in the distal rectum, 4 cm from the anal margin. Histopathological examination revealed shallow ulceration with fibrosis in lamina propria. We decided to treat the ulcer with one application of Purastat. Four weeks later, a follow-up colonoscopy revealed a complete mucosal healing with only mild residual mucosal erythema. Solitary Rectal Ulcer Syndrome (SRUS) is an uncommon benign proctologic disease usually affecting young adults with a prevalence of 1:100.000 per year, equally affecting women and men with a slight predominance in young women. SRUS is characterized by chronic rectal pain and bleeding, constipation, incomplete evacuation, tenesmus and mucous discharge impairing the patients' quality of life. In past years several topical agents have been used reporting clinical improvements, also if none of them has been evaluated in prospective controlled trials. Purastat (3D-Matrix Europe SAS, France) is a novel self-assembling peptide developed as a haemostatic agent for endoscopic and surgical procedures. In addition to the known haemostatic effect, it has been hypothesized that the activated Purastat nanostructure favors the cell and tissue proliferative process since the similarity of the activated Purastat 3-D nanostructure with the natural extracellular matrix (ECM-SM) scaffold material would result in an adequate adherence of cells and regenerative tissues, achieving more effective healing of the mucosa. Based on this hypothetical re-epithelizing property of Purastat, we decided to use it in this patient, achieving mucosal healing and symptoms improvement.

Fatal Outcome Consequent to an Endoscopic Full Thickness Resection of a Colonic Lateral Spreading Tumor: A Case Report.

BACKGROUND Endoscopic full-thickness resection represents an innovative procedure, used in selected patients that allows lesions en-bloc resection with an integral wall specimen available for histopathological definition. Bleeding and perforation are known to be the most frequent procedure-related adverse events. We report a case of entero-colonic fistula as complication of an endoscopic full-thickness resection. CASE REPORT A 77-year-old male, with a personal history of right-hemicolectomy for a colonic adenocarcinoma presented to our department for a routine colonoscopy that showed the presence of a 25 mm lateral spreading tumor localized at about 50 cm from the anal margin. A full-thickness resection of the lateral spreading tumor using the over-the-scope clip device was performed. After 4 weeks, because of abdominal pain, weight loss, diarrhea, and signs of malnutrition, the patient underwent a new colonoscopy showing hyperemic mucosa with ulcerations in all colonic segments and, at the site of the previous endoscopic full-thickness resection, an orifice of an entero-colonic fistula. The histological definition was suggestive for ulcerative proctocolitis and confirmed the presence of small bowel mucosa at fistula orifice. An intussusception at the level of fistula with consequent intestinal obstruction caused a worsening of clinical conditions and finally the patient death for a septic peritonitis. CONCLUSIONS Full thickness resection represents an innovative tool for en-bloc resection of gastrointestinal tumoral lesion, but procedural complications and limitations must be considered before performing this procedure.

Endoscopic papillary large balloon dilation in patients with large biliary stones and periampullary diverticula: Results of a multicentric series.

INTRODUCTION: Stone extraction represents the most frequent indication for endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic papillary large balloon dilation (EPLBD) is a recent introduced approach consisting of an endoscopic papillary large balloon dilation following limited endoscopic sphyncterotomy (ES), which has been proven to be safe and effective for extraction of large common bile duct (CBD) stones. Peri-ampullary diverticula (PAD) are described in 10-20% of patients undergoing ERCP. Aim of our study is to evaluate efficacy and safety of EPLBD for the extraction of large biliary stones in patients with PAD. METHODS: The prospectively collected endoscopy databases of 4 Italian ERCP high-volume centers were reviewed retrospectively, and all consecutive patients with an instrumental diagnosis of large biliary stones and PAD, between September 2014 and October 2016, were included in this study. RESULTS: Eighty-one patients (36 males, median age 75 years) were treated between September 2014 and October 2016. Deep biliary cannulation was reached in 78/80 patients. Successful extraction was achieved in 74/78 patients at the first attempt. AEs occurred in 8 patients (1 severe). Younger age, stone size and incomplete stone extraction were significantly associated with AEs. CONCLUSIONS: EPLBD is an effective and safe technique in patients with PAD and large biliary stones, which avoids the need of other techniques, thereby reducing the risks of adverse events.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones.

BACKGROUND & AIMS: It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001). CONCLUSIONS: In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

Efficacy and safety of endoscopic papillary balloon dilation for the removal of bile duct stones: Data from a "real-life" multicenter study on Dilation-Assisted Stone Extraction.

AIM: To report data on Dilation-Assisted Stone Extraction (DASE) use in clinical practice and its efficacy and safety trough three Italian referral centers for biliopancreatic diseases treatment. METHODS: From January 2011 to December 2015 we collected data on 120 patients treated with DASE. Technical success was obtained when the endoscopist was able to place the balloon trough the papilla inflating the balloon until the final diameter for an adequate time (at least 30 s). Clinical success was obtained after complete stone removal (no remaining stones were visible at the cholangiogram). RESULTS: Forty-nine male (40.8%) and 71 female (59%) were enrolled. The mean age was 67.8 years ± 15.7. The mean common bile duct (CBD) dilation was 19.2 mm ± 3.9 and the mean size of stones 15.8 ± 2.9. DASE was applied as first approach in 38% (62% after initial failure of stones extraction). Technical and clinical success was of 91% and 87% respectively. In those in which DASE failed alternative treatment were adopted. After DASE 18% of patients experienced a complication (bleeding 9%, pancreatitis 8%, perforation 0.8%). At univariable analysis, elective endoscopic retrograde cholangiopancreatography (P = 0.031), DASE as first approach (P = 0.032), and cannulation of major papilla followed by guidewire insertion (P = 0.004) were related to low risk of complications. Pre-cut was related to an increased risk of complications (P = 0.01). CONCLUSION: DASE allowed a higher first-session success rate and can be consider a valid alternative to endoscopic sphincterotomy not only for bigger CBD stones.