Off-label use of Lumen-apposing metal stents for treatment of short benign biliary strictures.

BACKGROUND: Endoscopic stenting is the mainstay of treatment for benign biliary strictures. There is a not-negligible rate of recurrence and stent migration. Lumen-apposing metal stents (LAMS) have a unique design with short length, large diameter and wide flanges which make them less prone to migration. AIMS: To describe the intraluminal use of LAMS to treat short benign biliary strictures. METHODS: All consecutive patients who underwent bi-flanged LAMS placement for benign biliary strictures, in approximately 6 years, were retrospectively included. Primary outcomes were technical and clinical success; secondary outcomes were number of endoscopic procedures, adverse events evaluation and stricture recurrence during follow-up. RESULTS: Seventy patients (35 male, mean age 67) were enrolled; bilio-enteric anastomotic stricture was the most common etiology. Technical and clinical success were 100 % and 85.7 %, respectively. Patients with post-surgical stricture had a higher success rate than patients with non-surgical stricture or with bilio-enteric anastomotic stricture (90.4 %, 86.3 % and 81.4 %, respectively). Adverse events were 12/70 (17.1 %): stent migration was the most frequent (8/70, 11.4 %). Stricture recurrence was found in 10/54 patients (18.5 %). CONCLUSION: LAMS placement could be safe and effective treatment for short benign biliary strictures in patients in which a significant caliber disproportion between stricture and the duct above was revealed.

Recurrence rate and management after endoscopic papillectomy in a tertiary referral center.

BACKGROUND AND STUDY AIMS: Endoscopic papillectomy (EP) is considered a safe procedure for ampullary lesions. Few data are available on management of residual and recurrent adenomas. The aims of the present study were to evaluate long-term recurrence rate, median time-to-recurrence after EP and treatment of both residual and recurrent adenomas. PATIENTS AND METHODS: Consecutive patients who underwent EP of major and minor papilla at our endoscopy center between 2011 and 2022 were enrolled. Residual adenoma was defined as the endoscopic evidence of adenomatous tissue after EP. Recurrent adenoma was defined as the presence of adenomatous tissue after the first endoscopic follow-up and complete adenoma resection. RESULTS: 95 patients satisfied the inclusion criteria. Pathology after resection showed adenoma with low-grade dysplasia (LGD) in 52 patients, high-grade dysplasia (HGD) in 25 patients, adenocarcinoma in 6 patients, NET in 4 patients and not-neoplastic duodenal mucosa in 8 patients. Adverse events occurred in 25 % of patients. The median follow-up after EP was 22.5 months. Local residual was observed in 27 patients (28,4 %) and recurrence after the endoscopic retreatments occurred in 11 patients (11,6 %). Furthermore, recurrence occurred in 16 of 68 patients with adenoma-free after a first endoscopic follow-up and 9 patients developed at least a second recurrence. All the recurrences but one were endoscopically treated. CONCLUSIONS: EP and its ancillary treatments for residual and recurrent adenomas is an effective treatment for ampullary tumors. Long-term surveillance demonstrates that recurrences can be mainly treated endoscopically.

Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma.

BACKGROUND: Insulinoma is the most common functional pancreatic neuroendocrine tumor and treatment is required to address symptoms associated with insulin hypersecretion. Surgical resection is effective but burdened by high rate of adverse events (AEs). Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) demonstrated encouraging results in terms of safety and efficacy for the management of these tumors. However, studies comparing surgery and EUS-RFA are lacking. AIMS: The primary aim is to compare EUS-RFA with surgery in term of safety (overall rate of AEs). Secondary endpoints include: (a) severe AEs rate; (b) clinical effectiveness; (c) patient's quality of life; (d) length of hospital stay; (e) rate of local/distance recurrence; (f) need of reintervention; (g) rate of endocrine and exocrine pancreatic insufficiency; (h) factors associated with EUS-RFA related AEs and clinical effectiveness. METHODS: ERASIN-RCT is an international randomized superiority ongoing trial in four countries. Sixty patients will be randomized in two arms (EUS-RFA vs surgery) and outcomes compared. Two EUS-RFA sessions will be allowed to achieve symptoms resolution. Randomization and data collection will be performed online. DISCUSSION: This study will ascertain if EUS-RFA can become the first-line therapy for management of small, sporadic, pancreatic insulinoma and be included in a step-up approach in case of clinical failure.

Garlic consumption in relation to colorectal cancer risk and to alterations of blood bacterial DNA.

PURPOSE: Garlic consumption has been inversely associated to intestinal adenoma (IA) and colorectal cancer (CRC) risk, although evidence is not consistent. Gut microbiota has been implied in CRC pathogenesis and is also influenced by garlic consumption. We analyzed whether dietary garlic influence CRC risk and bacterial DNA in blood. METHODS: We conducted a case-control study in Italy involving 100 incident CRC cases, 100 IA and 100 healthy controls matched by center, sex and age. We used a validated food frequency questionnaire to assess dietary habits and garlic consumption. Blood bacterial DNA profile was estimated using qPCR and16S rRNA gene profiling. We derived odds ratios (ORs) and the corresponding 95% confidence intervals (CIs) of IA and CRC according to garlic consumption from multiple conditional logistic regression. We used Mann-Whitney and chi-square tests to evaluate taxa differences in abundance and prevalence. RESULTS: The OR of CRC for medium/high versus low/null garlic consumption was 0.27 (95% CI = 0.11-0.66). Differences in garlic consumption were found for selected blood bacterial taxa. Medium/high garlic consumption was associated to an increase of Corynebacteriales order, Nocardiaceae family and Rhodococcus genus, and to a decrease of Family XI and Finegoldia genus. CONCLUSIONS: The study adds data on the protective effect of dietary garlic on CRC risk. Moreover, it supports evidence of a translocation of bacterial material to bloodstream and corroborates the hypothesis of a diet-microbiota axis as a mechanism behind the role of garlic in CRC prevention.

Endoscopic entero-enteral bypass to treat postsurgical benign complications of hepatico-jejunostomy: Update of a 7-year single-center experience.

Background and study aims Since 2014, we have been using a new endoscopic approach to improve management of biliary adverse events (BAEs) after bilio-digestive anastomosis. We provide an update about our experience at 7 years. Patients and methods Patients with BAEs on hepatico-jejunostomy underwent entero-enteral endoscopic by-pass (EEEB) creation between the duodenal/gastric wall and the biliary jejunal loop. Evaluation of results during our seven-year experience was performed. Results Eighty consecutive patients (32 patients from Jan 2014 to Dec 2017 and 48 patients from Jan 2018 to Jan 2021) underwent EEEB, which was successful in all but one patient. The cumulative AEs rate was 32 %. Endoscopic retrograde cholangiography (ERC) through the EEEB successfully treated all types of BAEs in these patients. Cumulative disease recurrence was 3.8 % (three patients) and was retreated through the EEEB. Conclusions The update of our experience with EEEB confirmed that in patients with BAEs after bilio-digestive anastomosis, EEEB allows successful long-term treatment of different BAEs in a tertiary referral center with an acceptable rate of related AEs.

Flavonoid Intake in Relation to Colorectal Cancer Risk and Blood Bacterial DNA.

Flavonoids have been inversely associated to colorectal cancer (CRC) and are plausible intermediaries for the relation among gut microbiome, intestinal permeability and CRC. We analyzed the relation of flavonoid intake with CRC and blood bacterial DNA. We conducted a case-control study in Italy involving 100 incident CRC cases and 200 controls. A valid and reproducible food-frequency questionnaire was used to assess dietary habits and to estimate six flavonoid subclass intakes. We applied qPCR and 16S rRNA gene profiling to assess blood bacterial DNA. We used multiple logistic regression to derive odds ratios (ORs) of CRC and Mann-Whitney and chi--square tests to evaluate abundance and prevalence of operational taxonomic units (OTUs) according to flavonoid intakes. Inverse associations with CRC were found for anthocyanidins (OR for the highest versus the lowest tertile = 0.24, 95% confidence interval, CI = 0.11-0.52) and flavanones (OR = 0.18, 95% CI = 0.08-0.42). We found different abundance and prevalence according to anthocyanidin and flavanone intake for OTUs referring to Oligoflexales order, Diplorickettsiaceae family, Staphylococcus, Brevundimonas, Pelomonas and Escherischia-Shigella genera, and Flavobacterium and Legionella species. The study provides evidence to a protective effect of dietary anthocyanidins and flavanones on CRC and suggests an influence of flavonoids on blood bacterial DNA, possibly through intestinal permeability changes.

Non-intubated general anesthesia in prone position for advanced biliopancreatic therapeutic endoscopy: A single tertiary referral center experience.

Background and Study Aim: Advance biliopancreatic endoscopies are nowadays performed in non-operating room anesthesia (NORA) under general anesthesia (GA). We evaluate the outcomes of non-intubated patients in prone position who received GA for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) in a tertiary referral center for digestive endoscopy. Patients and Methods: Anesthesiological records, anamnestic, and intraoperative data of patients who underwent advanced therapeutic biliopancreatic endoscopies at our tertiary referral center from January 2019 until January 2020 were collected in the present observational study. Results: One hundred fifty-three patients (93 M; median age: 68-year-old; mean ASA status: 2) were considered eligible for a procedure in the prone position with GA in spontaneous breathing. Prone position was always the initial setting. Propofol administration through a target-controlled infusion (TCI) pump was the choice to achieve GA. In our experience, desaturation appears to be the most frequent adverse event, accounting for 35% of cases (55/153). Treatment foresaw additional oxygen through a nasopharyngeal catheter, which proved to be a sufficient measure in almost all patients (52/55). Other adverse events (i.e., inadequate sedative plan, pain, and bradycardia) accounted for 2.6% of cases (4/153). Conclusions: Non-intubated GA in the prone position may be regarded as a safe procedure, as long as the anesthesiological criteria of exclusion are respected and the anesthesiological team has become acquainted with the peculiar NORA setting and familiar with the management of possible adverse events.

Blood Bacterial DNA Load and Profiling Differ in Colorectal Cancer Patients Compared to Tumor-Free Controls.

Inflammation and immunity are linked to intestinal adenoma (IA) and colorectal cancer (CRC) development. The gut microbiota is associated with CRC risk. Epithelial barrier dysfunction can occur, possibly leading to increased intestinal permeability in CRC patients. We conducted a case-control study including 100 incident histologically confirmed CRC cases, and 100 IA and 100 healthy subjects, matched to cases by center, sex and age. We performed 16S rRNA gene analysis of blood and applied conditional logistic regression. Further analyses were based on negative binomial distribution normalization and Random Forest algorithm. We found an overrepresentation of blood 16S rRNA gene copies in colon cancer as compared to tumor-free controls. For high levels of gene copies, community diversity was higher in colon cancer cases than controls. Bacterial taxa and operational taxonomic unit abundances were different between groups and were able to predict CRC with an accuracy of 0.70. Our data support the hypothesis of a higher passage of bacteria from gastrointestinal tract to bloodstream in colon cancer. This result can be applied on non-invasive diagnostic tests for colon cancer control.

Endoscopic Vacuum Therapy (EVT) for Persistent Duodenal Stump Dehiscence After Upper Gastrointestinal Surgery in Selected Patients: A Tertiary Referral Center Case Series.

INTRODUCTION: The usefulness of endoscopic vacuum therapy (EVT) in the setting of postoperative gastrointestinal leaks is widely described. On this basis, we would like to focus a specific application of EVT: the dehiscence of the duodenal stump after upper gastrointestinal surgery. Standard EVT is not applicable in these cases because of technical limitations (length of overtube and devices). However, vacuum stimulates the healing of leaks and fistulas through granulation tissue's formation and would be effective also in this setting. MATERIALS AND METHODS: Between October 2019 and January 2020, 7 consecutive patients (4 M, 3 F, 62±9 y old) affected by duodenal stump's dehiscence were endoscopically treated by the placement of a large-bore (14 to 18 Ch) suction tube across the wall's defect into the peritoneal cavity. Continuous aspiration at -80/-100 mm Hg was applied. Clinical success was established both by fluoroscopic check injecting contrast medium from the tube to verify the fistula's closure and by abdominal computed tomography scan to exclude residual fluid collections. RESULTS: Technical and clinical success were achieved in all the patients. The suction tube was maintained in site for 12±5 days in continuous aspiration. The drainage's output became null in 2±1 days without any intra-abdominal residual fluid collection. The principle of this technique is to let the duodenal walls' stump to collapse on the intraluminal part of the tube (with subsequent mucosal intussusception into the holes of the tube itself) creating a sort of vacuum-packed barrier to interrupt the outflow of enteric materials into the fistula's path. It guarantees the fistula's closure by the gradual formation of granulation tissue. CONCLUSIONS: The present technique offers a safe and viable endoscopic alternative to treat duodenal stump's leaks after upper gastrointestinal surgery.

Erratum: Endoscopic 'suction room' to treat complex enteral stump leaks after upper gastrointestinal surgery.

[This corrects the article DOI: 10.1055/a-1336-2922.].

Endoscopic 'suction room' to treat complex enteral stump leaks after upper gastrointestinal surgery.

Leaks/dehiscence of the enteral stump associated with infected peri-enteric collections after upper gastrointestinal surgery are a life-threatening adverse event, not usually endoscopically treatable. We describe a new endoscopic approach to treat complex entero-cutaneous fistulas (CECF) by creating a "suction room" through placement of multiple stents (enteral, biliary and/or pancreatic) and a large nose-enteral suction tube inside the enteral stent maintained on a continuous negative aspiration suction. Between January 2016 and December 2019, six consecutive patients referred to our unit with CECF of the enteral stump after failed redo surgeries underwent creation of a "suction room." In five patients, enteral, biliary and pancreatic stents were positioned before a nose-to-stent or nose-to-collection large 18 Fr tube placement. In one patient, a pancreatic stent was not placed. Technical and clinical success were achieved in all patients. Mean and median times of aspiration were 49 and 27 days, respectively, with a mean hospital stay of 56 days after the endoscopic procedure. Stents were successfully removed. Mean post-procedural follow-up was 17.3 months. Endoscopic creation of the "suction room" offers the unique possibility of treating complex entero-cutaneous fistulas in surgically altered sites, which are difficult to manage with standard endoscopic methods.

Expanding endoscopic treatment strategies for pancreatic leaks following pancreato-duodenectomy: a single centre experience.

BACKGROUND AND AIM: Clinically relevant pancreatic leaks of jejunal-pancreatic anastomosis after pancreato-duodenectomy (PD) occur in 9-15% of cases. Endoscopic strategies for management of pancreatic fistula, may allow to avoid reoperation and shorten times for fistula closure, but are still understudied and not widely performed. Aim of the present paper is to describe different endoscopic techniques used to treat such conditions. METHODS: It was a retrospective, single centre, study. All patients who underwent endoscopic treatment for pancreatic leaks following PD between 1st January 2013 and 31th May 2019 at our Centre were reviewed. Depending on the morphology and severity of the leak, four main endoscopic techniques were performed: (1) trans-anastomotic intraductal pancreatic stent insertion; (2) lumen-apposing metal stent between the jejunal loop and the retroperitoneum toward the pancreatic stump insertion ("yoyo-stent"); (3) large calibre nose-to-retroperitoneum drain insertion; (4) when a wide damage of the jejunal wall or a coexistent biliary-jejunal leak were observed, triple metal stent insertion was performed as follow in order to close the defect: enteral fully-covered SEMS in the jejunal stump, a pancreatic metal stent into the Wirsung duct and a fully-covered SEMS across the bilio-digestive anastomosis, through the meshes of the enteral stent. In all cases, surgical drain was simultaneously retracted. RESULTS: We identified 13 patients who underwent endoscopic treatment for POPF after PD. In total, 5 patients underwent "Yoyo stent insertion", 3 with nose-to-collection drain placement and four patients were treated with triple-stent insertion; in only one patient intrapancreatic SEMS insertion was performed. Technical success was 100% and clinical success was 83.3%. Mean time for leak closure was 4.8 days (range 2-10). During the follow-up interval, no leak recurrences were observed. CONCLUSIONS: Our experience confirms efficacy and safety of endoscopic management of POPF following pancreatoduodenectomy management. Endoscopy should play a central role in this clinical scenario.