Success Rate of Fiducial Markers Placement for Treatment of Esophageal or Rectal Cancers, a prospective multicenter study (FIDECHO study).

BACKGROUND AND STUDY AIMS: Endoscopy Ultra-Sound (EUS)-guided fiducial marker placement in patients with esophageal or rectal cancer who have been referred for radiation therapy lacks data regarding its feasibility and safety. The aim of this study was to assess the success rate of EUS-guided fiducial marker placement in these indications. PATIENTS AND METHODS: This prospective multicenter study enrolled patients with rectal or esophageal tumor, who were treated between March 2017 and June 2021. The primary endpoint was the success of fiducial markers placement under EUS guidance utilizing the preloaded 22-gauge EchoTip Ultra Fiducial needle® (Cook Medical, Limerick, Ireland), defined by the ability to release fiducials at least at proximal and distal ends of the tumor. The secondary endpoints were the adverse events, length of procedure, and remaining fiducial markers throughout radiation therapy. RESULTS: A total of 33 patients were included in this study, with a mean age of 64.2 years ±11.3, and 66.7% of males. Twenty patients had rectal adenocarcinoma, and 13 had esophageal malignancies. The success rate of fiducial markers placement was 93.9%. Markers could only be released at the proximal end of the tumor in two cases. The average procedure time (±SD) was 12.5 min (±4.8). The number of fiducial markers placed for each patient was 3.8 (±0.5). No adverse event was reported. At the end of radiotherapy, markers were still visible on imaging in all patients. CONCLUSION: This prospective multicenter study highlights the safety and high success of the placement of fiducial markers under EUS, for rectal and esophageal tumors, without adverse event, and with a short procedure time. Fiducial markers remain in place over time during radiation therapy. CLINICALTRIALS: gov ID: NCT03057288.

The environmental impact of small-bowel capsule endoscopy.

INTRODUCTION: The environmental impact of endoscopy, including small-bowel capsule endoscopy (SBCE), is a topic of growing attention and concern. This study aimed to evaluate the greenhouse gas (GHG) emissions (kgCO2) generated by an SBCE procedure. METHODS: Life cycle assessment methodology (ISO 14040) was used to evaluate three brands of SBCE device and included emissions generated by patient travel, bowel preparation, capsule examination, and video recording. A survey of 87 physicians and 120 patients was conducted to obtain data on travel, activities undertaken during the procedure, and awareness of environmental impacts. RESULTS: The capsule itself (4 g) accounted for < 6 % of the total product weight. Packaging (43-119 g) accounted for 9 %-97 % of total weight, and included deactivation magnets (5 g [4 %-6 %]) and paper instructions (11-50 g [up to 40 %]). A full SBCE procedure generated approximately 20 kgCO2, with 0.04 kgCO2 (0.2 %) attributable to the capsule itself and 18 kgCO2 (94.7 %) generated by patient travel. Capsule retrieval using a dedicated device would add 0.98 kgCO2 to the carbon footprint. Capsule deconstruction revealed materials (e. g. neodymium) that are prohibited from environmental disposal; 76 % of patients were not aware of the illegal nature of capsule disposal via wastewater, and 63 % would have been willing to retrieve it. The carbon impact of data storage and capsule reading was negligible. CONCLUSION: The carbon footprint of SBCE is mainly determined by patient travel. The capsule device itself has a relatively low carbon footprint. Given that disposal of capsule components via wastewater is illegal, retrieval of the capsule is necessary but would likely be associated with an increase in device-related emissions.

The PRSS3P2 and TRY7 deletion copy number variant modifies risk for chronic pancreatitis.

BACKGROUND: PRSS1 and PRSS2 constitute the only functional copies of a tandemly-arranged five-trypsinogen-gene cluster (i.e., PRSS1, PRSS3P1, PRSS3P2, TRY7 and PRSS2) on chromosome 7q35. Variants in PRSS1 and PRSS2, including missense and copy number variants (CNVs), have been reported to predispose to or protect against chronic pancreatitis (CP). We wondered whether a common trypsinogen pseudogene deletion CNV (that removes two of the three trypsinogen pseudogenes, PRSS3P2 and TRY7) might be associated with CP causation/predisposition. METHODS: We analyzed the common PRSS3P2 and TRY7 deletion CNV in a total of 1536 CP patients and 3506 controls from France, Germany, India and Japan by means of quantitative fluorescent multiplex polymerase chain reaction. RESULTS: We demonstrated that the deletion CNV variant was associated with a protective effect against CP in the French, German and Japanese cohorts whilst a trend toward the same association was noted in the Indian cohort. Meta-analysis under a dominant model yielded a pooled odds ratio (OR) of 0.68 (95% confidence interval (CI) 0.52-0.89; p = 0.005) whereas an allele-based meta-analysis yielded a pooled OR of 0.84 (95% CI 0.77-0.92; p = 0.0001). This protective effect is explicable by reference to the recent finding that the still functional PRSS3P2/TRY7 pseudogene enhancers upregulate pancreatic PRSS2 expression. CONCLUSIONS: The common PRSS3P2 and TRY7 deletion CNV was associated with a reduced risk for CP. This finding provides additional support for the emerging view that dysregulated PRSS2 expression represents a discrete mechanism underlying CP predisposition or protection.

Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome.

BACKGROUND : The diagnosis of cholangiocarcinoma in patients with a biliary stricture without mass syndrome can be obtained by biliary brushing with a sensitivity of ~50 %. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were to compare sensitivity for cholangiocarcinoma diagnosis and cellularity obtained. METHODS : Biliary brushing was performed consecutively with each brush, in a randomized order. Cytological material was studied with blinding to the brush type used and order. The primary end point was sensitivity for cholangiocarcinoma diagnosis; the secondary end point was the abundance of cellularity obtained with each brush, with cellularity quantified in order to determine if one brush strongly outperformed the other. RESULTS : 51 patients were included. Final diagnoses were cholangiocarcinoma (n = 43; 84 %), benign (n = 7; 14 %), and indeterminate (n = 1; 2 %). Sensitivity for cholangiocarcinoma was 79 % (34 /43) for the Infinity brush versus 67 % (29/43) for the RX Cytology Brush (P = 0.10). Cellularity was rich in 31/51 cases (61 %) with the Infinity brush and in 10/51 cases (20 %) with the RX Cytology Brush (P < 0.001). In terms of quantification of cellularity, the Infinity brush strongly outperformed the RX Cytology Brush in 28/51 cases (55 %), while the RX Cytology Brush strongly outperformed the Infinity brush in 4/51 cases (8 %; P < 0.001). CONCLUSIONS : This randomized crossover trial showed that the Infinity brush is not significantly more effective than the RX Cytology Brush for biliary stenosis without mass syndrome in terms of sensitivity for cholangiocarcinoma diagnosis, but does offer a significantly higher abundance of cellularity.

Use of endoscopic submucosal dissection or full-thickness resection device to treat residual colorectal neoplasia after endoscopic resection: a multicenter historical cohort study.

INTRODUCTION : Residual colorectal neoplasia (RCN) after previous endoscopic mucosal resection is a frequent challenge. Different management techniques are feasible including endoscopic full-thickness resection using the full-thickness resection device (FTRD) system and endoscopic submucosal dissection (ESD). We aimed to compare the efficacy and safety of these two techniques for the treatment of such lesions. METHODS : All consecutive patients with RCN treated either using the FTRD or by ESD were retrospectively included in this multicenter study. The primary outcome was the R0 resection rate, defined as an en bloc resection with histologically tumor-free lateral and deep margins. RESULTS : 275 patients (median age 70 years; 160 men) who underwent 177 ESD and 98 FTRD procedures for RCN were included. R0 resection was achieved in 83.3 % and 77.6 % for ESD and FTRD, respectively (P = 0.25). Lesions treated by ESD were however larger than those treated by FTRD (P < 0.001). The R0 rates for lesions of 20-30 mm were 83.9 % and 57.1 % in the ESD and FTRD groups, respectively, and for lesions of 30-40 mm were 93.6 % and 33.3 %, respectively. On multivariable analysis, ESD procedures were associated with statistically higher en bloc and R0 resection rates after adjustment for lesion size (P = 0.02 and P < 0.001, respectively). The adverse event rate was higher in the ESD group (16.3 % vs. 5.1 %), mostly owing to intraoperative perforations. CONCLUSION: ESD is effective in achieving R0 resection for RCN whatever the size and location of the lesions. When residual lesions are smaller than 20 mm, the FTRD is an effective alternative.

Endoscopic internal drainage and low negative-pressure endoscopic vacuum therapy for anastomotic leaks after oncologic upper gastrointestinal surgery.

BACKGROUND: Endoscopic internal drainage (EID) with double-pigtail stents or low negative-pressure endoscopic vacuum therapy (EVT) are treatment options for leakage after upper gastrointestinal oncologic surgery. We aimed to compare the effectiveness of these techniques. METHODS: Between 2016 and 2019, patients treated with EID in five centers in France and with EVT in Göttingen, Germany were included and retrospectively analyzed using univariate analysis. Pigtail stents were changed every 4 weeks; EVT was repeated every 3-4 days until leak closure. RESULTS: 35 EID and 27 EVT patients were included, with a median (interquartile range [IQR]) leak size of 0.75 cm (0.5-1.5). Overall treatment success was 100 % (95 % confidence interval [CI] 90 %-100 %) for EID vs. 85.2 % (95 %CI 66.3 %-95.8 %) for EVT (P = 0.03). The median (IQR) number of endoscopic procedures was 2 (2-3) vs. 3 (2-6.5; P = 0.003) and the median (IQR) treatment duration was 42 days (28-60) vs. 17 days (7.5-28; P < 0.001), for EID vs. EVT, respectively. CONCLUSION: EID and EVT provide high closure rates for upper gastrointestinal anastomotic leaks. EVT provides a shorter treatment duration, at the cost of a higher number of procedures.

Minimally invasive drainage in critically ill patients with severe necrotizing pancreatitis is associated with better outcomes: an observational study.

BACKGROUND: Infected pancreatic necrosis, which occurs in about 40% of patients admitted for acute necrotizing pancreatitis, requires combined antibiotic therapy and local drainage. Since 2010, drainage by open surgical necrosectomy has been increasingly replaced by less invasive methods such as percutaneous radiological drainage, endoscopic necrosectomy, and laparoscopic surgery, which proved effective in small randomized controlled trials in highly selected patients. Few studies have evaluated minimally invasive drainage methods used under the conditions of everyday hospital practice. The aim of this study was to determine whether, compared with conventional open surgery, minimally invasive drainage was associated with improved outcomes of critically ill patients with infection complicating acute necrotizing pancreatitis. METHODS: A single-center observational study was conducted in patients admitted to the intensive care unit for severe acute necrotizing pancreatitis to compare the characteristics, drainage techniques, and outcomes of the 62 patients managed between September 2006 and December 2010, chiefly with conventional open surgery, and of the 81 patients managed between January 2011 and August 2015 after the introduction of a minimally invasive drainage protocol. RESULTS: Surgical necrosectomy was more common in the early period (74% versus 41%; P <0.001), and use of minimally invasive drainage increased between the early and late periods (19% and 52%, respectively; P <0.001). The numbers of ventilator-free days and catecholamine-free days by day 30 were higher during the later period. The proportions of patients discharged from intensive care within the first 30 days and from the hospital within the first 90 days were higher during the second period. Hospital mortality was not significantly different between the early and late periods (19% and 22%, respectively). CONCLUSION: In our study, the implementation of a minimally invasive drainage protocol in patients with infected pancreatic necrosis was associated with shorter times spent with organ dysfunction, in the intensive care unit, and in the hospital. Mortality was not significantly different. These results should be interpreted bearing in mind the limitations inherent in the before-after study design.

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02595853).

ERCP 2.0: Biliary 3D-reconstruction in patients with malignant hilar stricture.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) for malignant hilar strictures is challenging. The correlation between Magnetic resonance cholangiopancreatography (MRCP) and per ERCP 2D fluoroscopic images is not obvious. The aim of this study was to evaluate the feasibility and potential usefulness of MRCP-based handmade biliary 3D reconstruction in this setting. METHODS: Methods Patients who underwent MRCP followed by ERCP for biliary drainage of a malignant hilar stricture at our institution between 2018 and 2020 were reviewed. A handmade 3D segmentation using 3D slicer© (Kitware, France) was fashioned and reviewed with an expert radiologist. The primary outcome was the feasibility of biliary segmentation. RESULTS: A total of 16 patients were included. The mean age was 70.1 (+/- 8.6) years-old and 68.8% had hilar cholangiocarcinoma. Handmade segmentation was successful in all cases. The agreement between the MRCP interpretation and the 3D reconstruction was 37.5%, as per the Bismuth classification. 3D reconstruction available prior to ERCP could have helped guide for better stent placement in 11 cases (68.8%). CONCLUSIONS: MRCP-based biliary 3D segmentation-reconstruction, in patients with malignant hilar stricture is feasible and seems to provide a better anatomical understanding compared to MRCP and could help improve endoscopic management.

The level of glucose in pancreatic cyst fluid is more accurate than carcinoembryonic antigen to identify mucinous tumors: A French multicenter study.

Background and Objectives: Pancreatic cyst fluid level of glucose is a promising marker to identify mucinous from nonmucinous tumors, but the glucose assay has not yet been recommended. The objective of this study is to compare the diagnostic performances of pancreatic cyst fluid level of glucose and carcinoembryonic antigen (CEA). Methods: In this French multicenter study, data of consecutive patients who underwent fine-needle aspiration of pancreatic cyst with intracyst glucose assay between 2018 and 2022 were retrospectively reviewed. The area under the receiver operating characteristic curve (AUROC) of glucose and corresponding sensitivity (Se), specificity (Sp), accuracy (Acc), positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared with those of CEA. The best threshold of glucose was identified using the Youden index. Results: Of the 121 patients identified, 81 had a definitive diagnosis (46 mucinous, 35 nonmucinous tumors) and were included for analysis. An intracystic glucose level <41.8 mg/dL allowed identification of mucinous tumors with better diagnostic performances (AUROC, 93.6%; 95% confidence interval, 87.2%-100%; Se, 95.3%; Sp, 91.2%; Acc, 93.5%; PPV, 93.2%; NPV, 93.9%) compared with CEA level >192 ng/mL (AUROC, 81.2%; 95% confidence interval, 71.3%-91.1%; Se, 41.7%; Sp, 96.9%; Acc, 67.6%; PPV, 93.8%; NPV, 59.6%) (P = 0.035). Combining values of glucose and CEA did not offer additional benefit in terms of diagnosis. Conclusion: Our results confirm previously published data and support the use of pancreatic cyst fluid glucose for the identification of mucinous tumors when the definitive diagnosis remains uncertain.

Factors associated with diagnosis of obscure gastrointestinal bleeding by video capsule enteroscopy.

BACKGROUND & AIMS: Capsule enteroscopy (CE) is the best noninvasive tool to explore the entire small bowel of patients with obscure gastrointestinal bleeding (OGIB); it has a diagnostic yield of 40%-80%. However, little is known about the factors associated with a diagnosis of OGIB by CE. METHODS: We analyzed data from 911 consecutive patients who underwent CE for OGIB from January 2004 to January 2010. Results from upper and lower gastrointestinal endoscopy examinations were negative in all patients. CE findings were recorded. Features of patients that were associated with diagnosis of OGIB by CE were identified by using logistic regression. RESULTS: Based on CE, 509 patients (56%) had a confirmed lesion responsible for the OGIB: 203 had disease of the small bowel (22%), 88 had ulcerations (10%), 70 had tumors (8%), 24 had varices (2%), 6 had diverticula (0.5%), and 118 had what appeared to be bleeding lesions of the esophagus or stomach (10.6%) or colon (2%). Factors independently associated with a diagnosis of OGIB by CE were age >60 years (odds ratio [OR], 1.2), male sex, history of overt bleeding (OR, 3.8), and current hospitalization (OR, 1.4). Women were less likely to be diagnosed with OGIB by CE (OR, 0.7). CONCLUSIONS: A history of overt bleeding is the factor most strongly associated with a diagnosis of OGIB by CE. Male sex, age >60 years, and inpatient status were also independent predictors of positive diagnosis by CE.

Bacteria as trigger for chronic gastrointestinal disorders.

Apart from acute infections, microorganisms may also induce or perpetuate chronic inflammatory diseases and reversible or irreversible proliferation of various cells in the gastrointestinal tract (the extreme being adenocarcinoma and lymphoma). Helicobacter pylori is not only involved in the pathogenesis of lymphoma and gastric adenocarcinoma. The steps and mechanisms of the carcinogenic process involve host predisposition, environmental factors, and strain virulence. The steps of lymphoma genesis include chronic inflammation, acquisition of mucosa-associated lymphoid tissue in the stomach, proliferation of the B lymphocytes in an inflammatory context, acquisition of genetic anomalies and dysregulation of the NF-κB pathway. The role of Campylobacter jejuni in immunoproliferative small bowel disease has also been shown and eradication of this bacterium can cure the lymphoma at its early stage. The evidence for the role of some bacteria in colon cancer development is discussed. Opportunistic pathogens are detected in the stools or mucosa of a proportion of subjects with Crohn's disease. They include Mycobacterium avium paratuberculosis, adherent invasive Escherichia coli, and Clostridium difficile. A dysbiosis has been repeatedly observed in patients with inflammatory bowel disease. Instability of the dominant microbiota and decreased biodiversity (especially in the firmicutes phylum) are major characteristics. The decrease of Faecalibacterium prausnitzii seems to have a prognostic value to predict relapse of Crohn's disease after surgery. Finally, important perspectives are opened by new tools such as metagenomics and metabolomics of the gastrointestinal ecosystems. Major tracks concern irritable bowel syndrome, colon cancer and obesity.

Experience with the use of a hemostatic powder in 152 patients undergoing urgent endoscopy for gastrointestinal bleeding.

BACKGROUND AND STUDY AIMS: In the recent years, topical hemostatic powders have been used for the management of upper gastrointestinal bleeding. The aim of this study was to report on the use of an hemostatic powder (Hemospray®), outside regular hours, by on-call endoscopists during urgent endoscopic procedures. MATERIAL AND METHODS: In this retrospective multicenter cohort study, consecutive patients having undergone an urgent endoscopy with the use of Hemospray® from November 2015 to December 2018 in the Paris and suburbs area were included. We collected clinical, biological and endoscopic variables. The outcomes such as the recurrence, repeat endoscopy and hemostatic treatment need, complications and survival were also collected. RESULTS: A total of 152 patients (mean 65 years old, 70.4% male) were included. Amongst the 31 endoscopists, 11 were "more experienced", and performed 48% of the endoscopies. The most common causes of bleeding were peptic ulcer (47.7%), malignancy (22.2%) and esophagitis (12.4%). Most bleedings originated from the upper GI tract (95.0%). Hemospray® was used as a salvage therapy in 60.8% of cases. Other hemostatic techniques were used in 52.9% of cases. Immediate bleeding cessation was noted in 79.0% of cases, recurrence in 39.9% of cases, and 26.4% of patients benefited from a repeat endoscopic hemostasis. 34 (23.0%) patients required a non-endoscopic treatment. At day 30, the survival rate was 71.6%. One complication was reported (perforation). CONCLUSIONS: Hemostatic powder application by on-call endoscopists outside regular hours is technically feasible, but comes with a high risk of rebleeding in severely ill patients.