Efficacy of 1 L polyethylene glycol plus ascorbate versus 4 L polyethylene glycol in split-dose for colonoscopy cleansing in out and inpatient: A multicentre, randomized trial (OVER 2019).

BACKGROUND AND AIMS: Adequate bowel cleansing is essential for colonoscopy quality. A novel 1 L polyethylene glycol plus ascorbate (1 L PEG+ASC) solution has been recently introduced. Nevertheless, the efficacy of 1 L PEG+ASC as compared to that of high-volume bowel preparation in both inpatients and outpatients is still unclear. PATIENTS AND METHODS: This single-blinded, non-inferiority study randomized patients undergoing colonoscopy to receive split-dose 1 L PEG+ASC or 4 L PEG. The primary endpoint was the overall cleansing success. Secondary endpoints were excellent cleansing and high-quality cleansing of the right colon, as well as lesions detection rate, patient compliance, tolerability and safety. RESULTS: Overall, 478 patients were randomized to 1 L PEG+ASC (N = 236) or 4 L PEG (N = 242). The 1 L PEG+ASC showed higher cleansing success rate (91.8% vs 83.6%; P=0.01) and a high-quality cleansing of the right colon (52.3% and 38.5%; P=0.004) compared to 4 L PEG. Moreover, 1 L PEG+ASC achieved a higher cleansing success in out-patients (96.3%% vs 88.6%; P=0.018), and a similar success rate in the in-patients (84.7% vs 76.7%; P=0.18). Adenoma detection rate, tolerability and incidence of adverse events were comparable between preparations. CONCLUSIONS: The 1 L PEG+ASC showed higher efficacy in achieving adequate colon cleansing compared with 4 L PEG, particularly in the right colon. No differences in the tolerability and safety were detected.

Management of Leaks Following Laparoscopic Sleeve Gastrectomy Using Specifically Designed Large Covered Metal Stents.

BACKGROUND: Leaks are the major complication associated with laparoscopic sleeve gastrectomy. OBJECTIVE: The study aimed to assess the efficacy and safety of specifically designed large covered metal stents for the management of post-laparoscopic sleeve gastrectomy leaks. METHODS: Prospectively collected databases from three Italian Endoscopy Units were reviewed. The primary outcome of the study was to evaluate the clinical success of stents placement, defined as complete resolution of clinical and laboratory signs of sepsis with radiological evidence of leak closure. Secondary outcomes were stent-related adverse events and mortality. RESULTS: Twenty-one patients (67% females, mean age 45 years) were included in the study and a total of 26 stents were placed. Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 85.5% of patients. Stent-related adverse events occurred in 9 patients (43%), with stent migration as the most frequent complication (33%). Adverse events were more frequently observed in patients who had undergone bariatric surgery prior to laparoscopic sleeve gastrectomy compared to patients without previous surgery (83% et al. 27%, p=0.018). CONCLUSION: The placement of specifically designed covered metal stents appears to be an effective and safe therapeutic approach for post-laparoscopic sleeve gastrectomy leaks. Stent migration can be a frequent complication.

Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study.

BACKGROUND: The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had never been tested in the real-life. AIM: To assess the effectiveness and tolerability of the 1 L preparation compared to 4 L and 2 L- PEG solutions in a real-life setting. METHODS: All patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers from September 2018 to February 2019. The primary endpoints of the study were the assessment of bowel cleansing success and high-quality cleansing of the right colon. The secondary endpoints were the evaluation of tolerability, adherence and safety of the different bowel preparations. Bowel cleansing was assessed through the Boston Bowel Preparation Scale. Adherence was defined as consumption of at least 75% of each dose, while tolerability was evaluated through a semi-quantitative scale. Safety was systematically monitored through adverse events reporting. RESULTS: Overall, 1289 met the inclusion criteria and were enrolled in the study. Of these, 490 patients performed a 4 L-PEG preparation (Selgesse®), 566 a 2 L-PEG cleansing (Moviprep® or Clensia®) and 233 a 1 L-PEG preparation (Plenvu®). Bowel cleansing by Boston Bowel Preparation Scale was 6.5 ± 1.5 overall and 6.3 ± 1.5, 6.2 ± 1.5, 7.3 ± 1.5 (P < 0.001) in the subgroups of 4 L, 2 L and 1 L-PEG preparation, respectively. Cleansing success was achieved in 72.4%, 74.1% and 90.1% (P < 0.001), while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% (P < 0.001) for 4 L, 2 L and 1 L-PEG preparation groups, respectively. The 1 L preparation was the most tolerated compared to the 2 and 4 L-PEG solutions in the absence of serious adverse events within any of the three groups. Multiple regression models confirmed 1 L PEG-ASC preparation as an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability. CONCLUSION: This study supports the effectiveness and tolerability of 1 L PEG-ASC, also showing it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability.

Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients.

BACKGROUND: The guidewire biliary cannulation (GWC) technique may increase the cannulation rate and decrease the risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. The aim of our multicenter prospective randomized controlled trial was to determine if the use of an atraumatic loop-tip guidewire reduces the rate of post-ERCP pancreatitis (PEP) compared with the standard contrast-assisted cannulation (CC) technique. METHODS: From June 2012 to December 2013, a total of 320 patients who had a naïve papilla and were referred for ERCP were randomly assigned to the GWC group (n = 160) or the CC group (n = 160). GWC or CC was randomly used. In cases of failed cannulation in both arms after crossover, biliary access was attempted with alternative techniques (e. g., dual-wire technique, pancreatic duct stenting, precut). RESULTS: The biliary cannulation rates were 81 % in the GWC group and 73 % in the CC group (P = n. s.). Following crossover, cannulation was successful in 8 % and 11 % of patients in the GWC and CC groups, respectively. With use of an alternative technique, the cannulation rates were 98 % in the GWC group and 96 % in the CC group, respectively. The rates of PEP were 5 % in the GWC group and 12 % in the CC group (P = 0.027). The post-interventional complication rates did not differ between the two groups. CONCLUSION: GWC with the new wire guide is associated with a lower rate of PEP in comparison with the CC technique. Clinical trial reference number: NCT01771419.

For "difficult" benign colorectal lesions referred to surgical resection a second opinion by an experienced endoscopist is mandatory: A single centre experience.

AIM: To assess how many patients with benign "difficult" colorectal lesions (DCRLs) referred to surgical resection, may be treated with endoscopic resection (ER) rather than surgical resection. METHODS: The prospectively collected colonoscopy database of our Endoscopic Unit was reviewed to identify all consecutive patients who, between July 2011 and August 2013, underwent an endoscopic re-evaluation before surgical resection due to the presence of DCRLs with a histological confirmation of benignancy on forceps biopsy. ER was attempted when the lesion did not have definite features of deeply invasive cancer. The "nonlifting sign" excluded ER only in naive lesions without a prior attempted resection. Lesions were classified, using the Kyoto-Paris classification for mucosal neoplasia. For sessile and non-polypoid lesions the "inject and cut" resection technique was used. Pedunculated and semi-pedunculated lesions were transected at the stalk just below the polyps head and before or after resection, metal clips or a loop were applied on the stalk to prevent bleeding. The lesions were histologically classified according to the Vienna criteria and for the pedunculated lesions the Haggitt classification was used. RESULTS: Eighty-two patients (42 females, mean age 62 years) with 82 lesions (mean size 37 mm) were included in the study. Sixty-nine (84%) lesions were endoscopically resected, while 13 underwent surgical resection since ER was deemed unsuitable. On histology, cancer was found in 21/69 lesions (14 intra-mucosal, 7 sub-mucosal) and was associated with the size (P < 0.001) and with type 0-IIa +Is (P = 0.011) and 0-IIa + IIc (P < 0.001) lesions. All patients with sub-mucosal cancer, underwent surgical resection. Complications occurred in 11/69 patients (7 bleedings, 2 transmural burn syndromes, 2 perforations), all managed endoscopically or conservatively, and were associated with presence of invasive cancer (P = 0.021). During follow-up recurrence/residual tissue was found in 14/51 sessile or non-polypoid lesions (13 treated endoscopically, 1 underwent surgical resection) and was associated with type 0-IIa + Is lesions (P = 0.001), piecemeal resections (P = 0.01) and with lesion size (P = 0.004). Overall, 74% of patients avoided surgery. Surgical resection was significantly associated with type 0-IIa + Is (P = 0.01) and 0-IIa + IIc (P = 0.001) lesions, with sub-mucosal invasion on histology (P < 0.001), with presence of the "nonlifting sign" (P < 0.001), and related to the dimension of the lesions (P = 0.001). In the logistic regression analysis, the only independent predictor for surgical resection was the dimension of the lesions (P = 0.002). CONCLUSION: Before submitting patients to surgical resection for a benign DCRL, a second opinion by an experienced endoscopist is mandatory to avoid unnecessary surgery.

Role of stenting in gastrointestinal benign and malignant diseases.

Advances in stents design have led to a substantial increase in the use of stents for a variety of digestive diseases. Initially developed as a non-surgical treatment for palliation of esophageal cancer, the stents now have an emerging role in the management of malignant and benign conditions as well as in all segments of the gastrointestinal tract. In this review, relevant literature search and expert opinions have been used to evaluate the key-role of stenting in gastrointestinal benign and malignant diseases.

Role of endoscopy in management of gastrointestinal complications of portal hypertension.

The management of patients with gastrointestinal complications of portal hypertension is often complex and challenging. The endoscopy plays an important role in the management of these patients. The role of endoscopy is both diagnostic and interventional and in the last years the techniques have undergone a rapid expansion with the advent of different and novel endoscopic modalities, with consequent improvement of investigation and treatment of these patients. The choice of best therapeutic strategy depends on many factors: baseline disease, patient's clinical performance and the timing when it is done if in emergency or a prophylactic approaches. In this review we evaluate the endoscopic management of patients with the gastrointestinal complications of portal hypertension.

Endoscopic ultrasound-guided fine-needle biopsy of small solid pancreatic lesions using a 22-gauge needle with side fenestration.

BACKGROUND: Early detection of small pancreatic cancer is important because expected survival is markedly better for tumors ≤ 2 cm. A new endoscopic ultrasound-(EUS) guided biopsy needle with side fenestration has been recently developed to enable fine-needle biopsy (FNB) under EUS guidance. The aim of this study was to evaluate the outcome of EUS-FNB using a 22-gauge ProCore needle in solid pancreatic lesions ≤ 2 cm, in terms of diagnostic accuracy and yield. METHODS: From January 2011 to December 2012, all consecutive EUS-guided tissue sampling of small pancreatic lesions (≤ 2 cm) were performed using 22-gauge ProCore needles; the data of these patients were analyzed retrospectively. RESULTS: Sixty-eight patients with a mean age of 65.7 years were included. The mean lesion size was 16.5 mm (range 5-20). None of the patients developed complications. On pathological examination, the tissue retrieved was judged adequate in 58 out of 68 cases (85.3 %) and the presence of a tissue core was recorded in 36 out of 68 cases (52.9 %). The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 80, 100, 100, 40, and 82 %, respectively. CONCLUSION: Our results suggested that EUS-FNB of small pancreatic lesions using a 22-gauge ProCore needle is effective and safe, and supports our hypothesis that EUS-FNB is highly useful in establishing the nature of small pancreatic lesions.

Endoscopic ultrasound-guided treatments: are we getting evidence based--a systematic review.

The continued need to develop less invasive alternatives to surgical and radiologic interventions has driven the development of endoscopic ultrasound (EUS)-guided treatments. These include EUS-guided drainage of pancreatic fluid collections, EUS-guided necrosectomy, EUS-guided cholangiography and biliary drainage, EUS-guided pancreatography and pancreatic duct drainage, EUS-guided gallbladder drainage, EUS-guided drainage of abdominal and pelvic fluid collections, EUS-guided celiac plexus block and celiac plexus neurolysis, EUS-guided pancreatic cyst ablation, EUS-guided vascular interventions, EUS-guided delivery of antitumoral agents and EUS-guided fiducial placement and brachytherapy. However these procedures are technically challenging and require expertise in both EUS and interventional endoscopy, such as endoscopic retrograde cholangiopancreatography and gastrointestinal stenting. We undertook a systematic review to record the entire body of literature accumulated over the past 2 decades on EUS-guided interventions with the objective of performing a critical appraisal of published articles, based on the classification of studies according to levels of evidence, in order to assess the scientific progress made in this field.

Self-expandable metal stents for malignant colonic obstruction: data from a retrospective regional SIED-AIGO study.

BACKGROUND: Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery. AIMS: To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction. METHODS: Two hundred and four patients (male 54.9%, mean age of 69.5 ± 14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed. RESULTS: Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p=0.003), and chemotherapy with a lower risk of stent ingrowth (p=0.009). CONCLUSION: This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth.

Preoperative diagnosis of a solid pseudopapillary tumour of the pancreas by Endoscopic Ultrasound Fine Needle Biopsy: A retrospective case series.

BACKGROUND: A solid pseudopapillary tumour of the pancreas (SPTP) is a rare neoplasm. AIM: We herein present five cases of SPTP diagnosed using endoscopic ultrasound (EUS) guided fine-needle biopsy (FNB) using a needle with side fenestration (ProCore-needle). METHODS: From January 2011 to June 2012 in five patients with SPTP tissue acquisition was carried out with a 19-gauge (4 patients) or a 22-gauge (one patient) needle. RESULTS: The mean age of the patients was 30.8 years, the mean lesion size was 49mm and the most common location was the tail of the pancreas (3 cases). When the samples were evaluated macroscopically, small core fragments were observed in all cases. A preoperative diagnosis of SPTP was made in all patients on the basis of the histocytological and characteristic immunophenotypic patterns and was confirmed at final surgical histology. CONCLUSIONS: In our experience, EUS-FNB is an effective and secure method for a preoperative diagnosis of SPTP.

Endoscopic tattooing of gastrointestinal and pancreatic lesions.

The intraoperative identification of the lesions found at endoscopic examination is often difficult, especially during laparoscopic surgery. At present, the most used technique for the intraoperative detection of pathological lesions is endoscopic tattooing. The large majority of studies carried out concern colorectal lesions; however, endoscopic tattooing has also been described for esophageal, gastric, small bowel and, more recently, pancreatic lesions. In this review, the authors evaluated indications, substances used, injection techniques, accuracy, safety and, finally, the risk of complications related to this procedure.

Is Helicobacter pylori the infectious target to prevent gastric cancer? An interdisciplinary point of view.

Gastric carcinogenesis, which may well extend over decades, is characterized by a slow stepwise evolution from superficial gastritis to glandular atrophy, intestinal metaplasia, dysplasia, and finally, adenocarcinoma. This sequence provides an excellent opportunity for the prevention or early detection of the events preceding development of the neoplasm. In 1994, the International Agency for Research on Cancer defined Helicobacter pylori (H. pylori) as a group I carcinogen for gastric cancer (GC). Evidence supporting a causal association has been demonstrated by epidemiological data as well as by experimental animal models. A meta-analysis has shown an higher risk (odds ratio: 1.92) of progression to GC in infected compare to uninfected subjects, that increased to a value > 8 considering the surveys having a follow-up of more than 8 years. A crucial question remains whether and when precancerous lesions can reverse after H. pylori eradication. While several prospective studies have cast doubts about this reversibility others obtained opposing results. Currently, H. pylori is recognized as a necessary but insufficient cause of GC. The most accepted model of gastric carcinogenesis provides, like for other cancers, a multifactorial pathogenesis, linked with a number of initiators and other continuator agents. This review presents a multidisciplinary point of view to approaching the relationship between H. pylori infection and GC, focusing on the potential benefits of bacterial eradication in slowing down or in inducing regression of precancerous lesions.

Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity.

BACKGROUND: Intragastric balloon (BioEnterics Intragastric Balloon, BIB®) or pharmacotherapy are possible options for the treatment of obese patients when traditional approaches have failed. The aim of our study was to compare in obese patients the effect on weight loss and metabolic changes of lifestyle modifications associated with either BIB or pharmacotherapy or the two treatments in sequence as a maintenance strategy for weight loss. METHODS: Fifty obese patients were recruited and randomly assigned to lifestyle modifications combined with either BIB for 6 months (n = 30) or sibutramine (pharmacotherapy group) for 1 year (n = 20). After BIB removal, patients were randomly assigned to either correct lifestyle (BIB/lifestyle) or lifestyle plus pharmacotherapy (BIB/pharmacotherapy). RESULTS: At 6 months, patients treated with BIB lost significantly (P < 0.05) more weight (percent of initial weight lost, %IWL = 14.5 ± 1.2; percent of excess BMI lost, %EBL = 37.7 ± 3.2) than patients who received pharmacological treatment (%IWL = 9.1 ± 1.5, %EBL = 25.3 ± 4.1). At 1 year, the weight lost was significantly (P < 0.05) greater in patients treated with either BIB/pharmacotherapy (%IWL = 15.8 ± 2.3%, %EBL = 41.3 ± 6.7%) or BIB/lifestyle (%IWL = 14.3 ± 2.7, %EBL = 34.9 ± 6.5%) in respect to pharmacotherapy group (%IWL = 8.0 ± 1.4%, %EBL = 22.1 ± 3.9%). Moreover, patients treated sequentially with BIB/lifestyle or BIB/pharmacotherapy showed a significant (P < 0.05) improvement in insulin sensitivity and triglycerides levels. CONCLUSIONS: BIB represents an efficacious long-term obesity treatment when supplemental strategies, as lifestyle modifications or pharmacotherapy, are established for weight maintenance after its removal.