Endoscopic management of benign biliary strictures: Looking for the best stent to place.

Benign biliary strictures (BBS) might occur due to different pancreaticobiliary conditions. The etiology and location of biliary strictures are responsible of a wide array of clinical manifestations. The endoscopic approach endoscopic retrograde cholangiopancreatography represents the first-line treatment for BBS, considering interventional radiology and surgery when endoscopic treatment fails or it is not suitable. The purpose of this review is to provide an overview of possible endoscopic treatments for the optimal management of this subset of patients.

Robotic endoscopic submucosal dissection and full-thickness excision for laterally spreading tumors of the rectum.

Endoscopic submucosal dissection (ESD) is technically demanding and time-consuming. Moreover, it bears a high risk of adverse events compared to other endoscopic methods, due to the lack of tissue manipulation. Robotic technology can significantly reduce the time of the procedure and increase the rate of complete resection for ESD. In the case of an unclear deep margin it allows to proceed to the full-thickness excision of the bowel wall. While the gain over transanal endoscopic microsurgery (TEM) is limited today, the longer systems currently under development will allow these complex procedures to be performed at least in the left side of the colon. The Supplementary video shows the application of the Flex Robotic System to perform an ESD and a full-thickness excision.

Small bowel to closest human body surface distance calculation through a custom-made software using CT-based datasets.

Screening of the gastrointestinal tract is imperative for the detection and treatment of physiological and pathological disorders in humans. Ingestible devices (e.g., magnetic capsule endoscopes) represent an alternative to conventional flexible endoscopy for reducing the invasiveness of the procedure and the related patient's discomforts. However, to properly design localization and navigation strategies for capsule endoscopes, the knowledge of anatomical features is paramount. Therefore, authors developed a semi-automatic software for measuring the distance between the small bowel and the closest human external body surface, using CT colonography images. In this study, volumetric datasets of 30 patients were processed by gastrointestinal endoscopists with the dedicated custom-made software and results showed an average distance of 79.29 ± 23.85 mm.

Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).

Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06-0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01-1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.

Colonic Stenting in the Emergency Setting.

Nowadays, colorectal cancer (CRC) is the third most frequent cancer, and about a third of patients with CRC presents themselves with symptoms of large bowel obstruction. Historically, surgical resection was the treatment of choice for colonic obstruction, but this kind of approach is burdened by a high risk of postoperative morbidity and mortality. In recent times, the use of a colonic stent has been proposed to overcome the obstruction and transform an emergency surgical case into an elective one to avoid emergency surgery complications. Endoscopic stenting is the first-line treatment option in the palliative management of colonic obstruction, and there is sufficient scientific evidence to support this approach. However, endoscopic stent used as a bridge to surgery is not yet widely adopted because the concern was raised about the long-term survival and cancer safety of this approach. The recent scientific evidence has shown that this approach improves the short-term outcomes, such as postoperative complications and the stoma rate, without differences in long-term outcomes compared to emergency surgery. Therefore, the European Society for Gastrointestinal Endoscopy in 2020 has reconsidered stenting as a bridge to surgery as a valid alternative to emergency surgery.

Through-the-scope esophageal stent for the relief of malignant dysphagia: Results of a multicentric study (with video).

BACKGROUND AND AIM: In presence of malignant dysphagia, in patients unfit for surgery, the placement of a self-expandable metal stent (SEMS) represents a safe and effective palliative treatment. Esophageal stents (ES) present an over-the-wire mechanism where the stent is deployed under X-ray control. Recently a through-the-scope (TTS) ES was launched. The aim of our retrospective study is to assess the technical and clinical success of the new TTS-ES. MATERIALS AND METHODS: Patients with malignant dysphagia caused by esophageal cancer or ab-extrinsic compression, who underwent TTS esophageal stent in six Italian endoscopic referral centers, were retrospectively reviewed. RESULTS: A total of 40 patients were enrolled. TTS stent placement was successful in 39/40 patients (97.5%). 31 patients had an Ogilvie score of 4, nine an Ogilvie 3. After 2 weeks from stent placement 29 reported Ogilvie score of 0, eight a score of 1. None of the patients developed retrosternal pain requiring drugs. No patient experienced perforation, bleeding or migration. A total of seven patients (18%) developed dysphagia as late adverse event (AE). CONCLUSION: Through-the-scope ES presented less AEs, in terms of bleeding and perforation, if compared to the previous published data. An anti-migration system could be helpful, especially when the stent is placed for "ab-extrinseco" malignant dysphagia.

Robotic-Assisted Colonoscopy Platform with a Magnetically-Actuated Soft-Tethered Capsule.

Background and Aims: Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. Despite offering a prime paradigm for screening, CRC screening is often hampered by invasiveness. Endoo is a potentially painless colonoscopy method with an active locomotion tethered capsule offering diagnostic and therapeutic capabilities. Materials and Methods: The Endoo system comprises a soft-tethered capsule, which embeds a permanent magnet controlled by an external robot equipped with a second permanent magnet. Capsule navigation is achieved via closed-loop interaction between the two magnets. Ex-vivo tests were conducted by endoscopy experts and trainees to evaluate the basic key features, usability, and compliance in comparison with conventional colonoscopy (CC) in feasibility and pilot studies. Results: Endoo showed a 100% success rate in operating channel and target approach tests. Progression of the capsule was feasible and repeatable. The magnetic link was lost an average of 1.28 times per complete procedure but was restored in 100% of cases. The peak value of interaction forces was higher in the CC group than the Endoo group (4.12N vs. 1.17N). The cumulative interaction forces over time were higher in the CC group than the Endoo group between the splenic flexure and mid-transverse colon (16.53Ns vs. 1.67Ns, p < 0.001), as well as between the hepatic flexure and cecum (28.77Ns vs. 2.47Ns, p = 0.005). The polyp detection rates were comparable between groups (9.1 ± 0.9% vs. 8.7 ± 0.9%, CC and Endoo respectively, per procedure). Robotic colonoscopies were completed in 67% of the procedures performed with Endoo (53% experts and 100% trainees). Conclusions: Endoo allows smoother navigation than CC and possesses comparable features. Although further research is needed, magnetic capsule colonoscopy demonstrated promising results compared to CC.

Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).

OBJECTIVE: To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. BACKGROUND: While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. METHODS: Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals. CONCLUSIONS: This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.

Intraoperative use of fluorescence with indocyanine green reduces anastomotic leak rates in rectal cancer surgery: an individual participant data analysis.

BACKGROUND: Fluorescence imaging by means of Indocyanine green (ICG) has been applied to intraoperatively determine the perfusion of the anastomosis. The purpose of this Individual Participant Database meta-analysis was to assess the effectiveness in decreasing the incidence of anastomotic leak (AL) after rectal cancer surgery. METHODS: We searched PubMed, Embase, Cochrane Library and ClinicalTrial.gov, EU Clinical Trials and ISRCTN registries on September 1st, 2019. We considered eligible those studies comparing the assessment of anastomotic perfusion during rectal cancer surgery by intraoperative use of ICG fluorescence compared with standard practice. We defined as primary outcome the incidence of AL at 30 days after surgery. The studies were assessed for quality by means of the ROBINS-I and the Cochrane risk tools. We calculated odds ratios (ORs) using the Individual patient data analysis, restricted to rectal lesions, according to original treatment allocation. RESULTS: The review of the literature and international registries produced 15 published studies and 5 ongoing trials, for 9 of which the authors accepted to share individual participant data. 314 patients from two randomized trials, 452 from three prospective series and 564 from 4 non-randomized studies were included. Fluorescence imaging significantly reduced the incidence of AL (OR 0.341; 95% CI 0.220-0.530; p < 0.001), independent of age, gender, BMI, tumour and anastomotic distance from the anal verge and neoadjuvant therapy. Also, overall morbidity and reintervention rate were positively influenced by the use of ICG. CONCLUSIONS: The incidence of AL may be reduced when ICG fluorescence imaging is used to assess the perfusion of a colorectal anastomosis. Limitations relate to the consistent number of non-randomized studies included and their heterogeneity in defining and assessing AL. Ongoing large randomized studies will help to determine the exact role of routine ICG fluorescence imaging may decrease the incidence of AL in surgery for rectal cancer.

Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial).

BACKGROUND: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction. METHODS: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far. CONCLUSIONS: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands.