Success rate of fiducial marker placement for treatment of esophageal or rectal cancers: a prospective multicenter study (FIDECHO study) (with video).

BACKGROUND AND AIMS: EUS-guided placement of fiducial markers 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. METHODS: This prospective multicenter study enrolled patients with rectal or esophageal tumors who were treated between March 2017 and June 2021. The primary endpoint was the success of fiducial marker 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 the proximal and distal ends of the tumor. Secondary endpoints were the adverse events, length of procedure, and fiducial markers remaining throughout radiation therapy. RESULTS: A total of 33 patients were included in this study, with a mean age of 64.2 ± 11.3 years; 66.7% were male. Twenty patients had rectal adenocarcinoma, and 13 had esophageal malignancies. The success rate of fiducial marker placement was 93.9%. Markers could only be released at the proximal end of the tumor in 2 cases. The average procedure time (±SD) was 12.5 ± 4.8 minutes. The number of fiducial markers placed for each patient was 3.8 ± .5. No adverse events were reported. At the end of radiotherapy, markers were still visible on imaging in all patients. CONCLUSIONS: This prospective multicenter study highlights the safety and high success of the placement of fiducial markers under EUS guidance for rectal and esophageal tumors, with no adverse events and with a short procedure time. Fiducial markers remained in place over time during radiation therapy. (Clinical trial registration number: NCT03057288.).

Impact of linked color imaging on the proximal adenoma miss rate: a multicenter tandem randomized controlled trial (the COCORICO trial).

BACKGROUND: Missed lesions are common during standard colonoscopy and are correlated with post-colonoscopy colorectal cancer. Contrast-enhanced technologies have recently been developed to improve polyp detection. We aimed to evaluate the impact of linked color imaging (LCI) on the proximal adenoma miss rate in routine colonoscopy. METHODS: This national, multicenter, tandem, randomized trial compared the outcomes of colonoscopy with white-light imaging (WLI) versus LCI for polyp detection in the right colon. Two consecutive examinations of the right colon (upstream of the hepatic flexure) were made with WLI and LCI by the same operator. First-pass examination by WLI or LCI was randomized 1:1 after cecal intubation. According to statistical calculations, 10 endoscopy units had to include approximately 700 patients. The primary outcome was proximal adenoma miss rate. Secondary outcomes were the proximal miss rates for sessile serrated lesions (SSL), advanced adenomas, and polyps. RESULTS: 764 patients were included from 1 January 2020 to 22 December 2022, and 686 patients were randomized (345 WLI first vs. 341 LCI first). Both groups were comparable in terms of demographics and indications. The proximal adenoma miss rate was not significantly higher in the WLI-first group (36.7%) vs. the LCI-first group (31.8%) (estimated mean absolute difference: 4.9% [95%CI -5.2% to 15.0%], P = 0.34). There was also no significant difference in miss rates for SSLs, advanced adenomas, and polyps in the proximal colon. CONCLUSIONS: In contrast to previous data, this study does not support the benefit of LCI to the proximal adenoma miss rate in routine colonoscopy.

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study).

BACKGROUND AND AIMS: EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. METHODS: A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. RESULTS: One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1 mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P = .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P < .001) and neoplasm size <20 mm (OR, 5.26; 95% CI, 2.17-14.29; P < .001) were independently related to complete tumor ablation. CONCLUSIONS: The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1 mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

Endoscopic resection of early esophageal tumors in patients with cirrhosis or portal hypertension: a multicenter observational study.

BACKGROUND: Liver cirrhosis and esophageal cancer share several risk factors, such as alcohol intake and excess weight. Endoscopic resection is the gold standard treatment for superficial tumors. Portal hypertension and coagulopathy may increase the bleeding risk in these patients. This study aimed to assess the safety and efficacy of endoscopic resection for early esophageal neoplasia in patients with cirrhosis or portal hypertension. METHODS: This retrospective multicenter international study included consecutive patients with cirrhosis or portal hypertension who underwent endoscopic resection in the esophagus from January 2005 to March 2021. RESULTS: 134 lesions in 112 patients were treated, including by endoscopic submucosal dissection in 101 cases (75 %). Most lesions (128/134, 96 %) were in patients with liver cirrhosis, with esophageal varices in 71 procedures. To prevent bleeding, 7 patients received a transjugular intrahepatic portosystemic shunt, 8 underwent endoscopic band ligation (EBL) before resection, 15 received vasoactive drugs, 8 received platelet transfusion, and 9 underwent EBL during the resection procedure. Rates of complete macroscopic resection, en bloc resection, and curative resection were 92 %, 86 %, and 63 %, respectively. Adverse events included 3 perforations, 8 delayed bleedings, 8 sepsis, 6 cirrhosis decompensations within 30 days, and 22 esophageal strictures; none required surgery. In univariate analysis, cap-assisted endoscopic mucosal resection was associated with delayed bleeding (P = 0.01). CONCLUSIONS: In patients with liver cirrhosis or portal hypertension, endoscopic resection of early esophageal neoplasia appeared to be effective and should be considered in expert centers with choice of resection technique, following European Society of Gastrointestinal Endoscopy guidelines to avoid undertreatment.

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.

Functionally deficient TRPV6 variants contribute to hereditary and familial chronic pancreatitis.

The recent discovery of TRPV6 as a pancreatitis susceptibility gene served to identify a novel mechanism of chronic pancreatitis (CP) due to Ca2+ dysregulation. Herein, we analyzed TRPV6 in 81 probands with hereditary CP (HCP), 204 probands with familial CP (FCP), and 462 patients with idiopathic CP (ICP) by targeted next-generation sequencing. We identified 25 rare nonsynonymous TRPV6 variants, 18 of which had not been previously reported. All 18 variants were characterized by a Ca2+ imaging assay, with 8 being identified as functionally deficient. Evaluation of functionally deficient variants in the three CP cohorts revealed two novel findings: (i) functionally deficient TRPV6 variants appear to occur more frequently in HCP/FCP patients than in ICP patients (3.2% vs. 1.5%) and (ii) functionally deficient TRPV6 variants found in HCP and FCP probands appear to be more frequently coinherited with known risk variants in SPINK1, CTRC, and/or CFTR than those found in ICP patients (66.7% vs 28.6%). Additionally, genetic analysis of available HCP and FCP family members revealed complex patterns of inheritance in some families. Our findings confirm that functionally deficient TRPV6 variants represent an important contributor to CP. Importantly, functionally deficient TRPV6 variants account for a significant proportion of cases of HCP/FCP.

Early Prediction of Acute Biliary Pancreatitis Using Clinical and Abdominal CT Features.

Background Assessment of the biliary origin of acute pancreatitis (AP) is crucial because it affects patient treatment to avoid recurrence. Although CT is systematically performed to determine severity in AP, its usefulness in assessing AP biliary origin has not been evaluated. Purpose To assess abdominal CT features associated with acute biliary pancreatitis (ABP) and to evaluate the predictive value of a combination of CT and clinical data for determining a biliary origin in a first episode of AP. Materials and Methods From December 2014 to May 2019, all consecutive patients who presented with a first episode of AP and with at least 6 months of follow-up were retrospectively reviewed. Evidence of gallstones was mandatory for a clinical diagnosis of ABP. Abdominal CT images were reviewed by two abdominal radiologists. Univariable and multivariable statistical analyses were performed, and a nomogram was constructed on the basis of the combination of clinical and CT features. This nomogram was validated in a further independent internal cohort of patients. Results A total of 271 patients (mean age ± standard deviation, 56 years ± 20; 160 men) were evaluated. Of these, 170 (63%) had ABP. At multivariable analysis, age (odds ratio [OR], 1.06; 95% CI: 1.03, 1.09; P < .001), alanine aminotransferase level (OR, 1.00; 95% CI: 1.00, 1.01; P = .009), gallbladder gallstone (OR, 15.59; 95% CI: 4.61, 68.62; P < .001), choledochal ring sign (OR, 5.73; 95% CI: 2.11, 17.05; P < .001), liver spontaneous attenuation (OR, 1.07; 95% CI: 1.04, 1.11; P < .001), and duodenal thickening (OR, 0.17; 95% CI: 0.03, 0.61; P = .01) were independently associated with ABP. The matching nomogram combining both clinical and CT features displayed an area under the curve of 0.94 (95% CI: 0.91, 0.97) in the study sample (n = 271) and 0.91 (95% CI: 0.84, 0.99) in the validation cohort (n = 51). Conclusion Abdominal CT provided useful features for diagnosis of acute biliary pancreatitis (ABP). Combining CT and clinical features in a nomogram showed good diagnostic performance for early diagnosis of ABP. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Chang in this issue.

IgA vasculitis in patients with inflammatory bowel disease: new insights into the role of TNF-α blockers.

OBJECTIVE: The association of IgA vasculitis (IgAV) and IBD is rarely described, mainly during anti-TNF-α therapy. We aimed to describe the association of IgAV and IBD. METHODS: We retrospectively analysed the association of IgAV and IBD through the implication of the GETAID and FVSG networks. Characteristics of IBD and IgAV were collected using a standardized case report form. RESULTS: Forty-three cases were included. IBD [mainly Crohn's disease (CD) in 58%] preceded IgAV in 38 (88%), with median interval of 9.2 (IQR 5.4-15.4) years. In these 38 patients, at IgAV diagnosis, five (13%) had active IBD and 28 (74%) were treated with anti-TNF-α for a median duration of 31.5 (IQR 19-56) months. Main IgAV manifestations were purpura all patients (100%), joints in 20/35 (57%), renal in 15/35 (43%) and gastrointestinal in 11/35 (31%) involvement. IgAV was treated with glucocorticoids in 25 (66%), colchicine in six (16%), CYC in six (16%) and anti-TNF-α were discontinued in 15/28 (54%). No IgAV relapse occurred when TNF-α blockers were stopped, vs 23% in patients pursuing it. Conversely, five (33%) had IBD flare or complication after anti-TNF-α cessation vs one (8%) in those continuing biologics. Anti-TNF-α were resumed in six (40%), with subsequent IgAV relapse in four (67%). CONCLUSIONS: This large cohort suggests that TNF-α blockers may promote the onset of IgAV in IBD. Discontinuation of anti-TNF-α was associated with vasculitis remission but increased risk of IBD relapses, whereas continuation of anti-TNF-α was associated with IBD remission but vasculitis relapse.

Safety of endoscopic retrograde cholangiopancreatography in the pediatric population: a multicenter study.

INTRODUCTION: The aims of this retrospective multicenter study were to assess the technical success and adverse events of endoscopic retrograde cholangiopancreatography (ERCP) procedures in children in French and Belgian centers. METHODS: All children aged 1 day to 17 years who underwent ERCP between January 2008 and March 2019 in 15 tertiary care hospitals were retrospectively included. RESULTS: 271 children underwent 470 ERCP procedures. Clinical long-term follow-up was available for 72 % of our patients (340/470 procedures). The median age at intervention was 10.9 years. ERCP was therapeutic in 90 % (423/470) and diagnostic in cases of neonatal cholestasis in 10 % of the patients. The most common biliary indication was choledocholithiasis; the most common pancreatic indication was chronic pancreatitis. Biliary cannulation was successful in 92 % of cases (270/294); pancreatic cannulation in 96 % of cases (169/176); and planned therapeutic procedures in 92 % of cases (388/423). The overall complication rate was 19 % (65/340). The most common complication was post-ERCP pancreatitis (PEP) in 12 % of cases (40/340) and sepsis in 5 % (18/340). On univariate analyses, pancreatic stent removal was protective against PEP (odds ratio [OR] 0.1, 95 % confidence interval [CI] 0.01 - 0.75; P = 0.03), and sepsis was associated with history of liver transplantation (OR 7.27, 95 %CI 1.7 - 31.05; P = 0.01). Five patients had post-ERCP hemorrhage and two had intestinal perforation. All complications were managed with supportive medical care. There was no procedure-related mortality. CONCLUSION: Our cohort demonstrates that ERCP can be performed safely with high success rates in many pancreaticobiliary diseases of children. The rate of adverse events was similar to that in previous reports.

Impact of the COVID-19 pandemic on gastrointestinal endoscopy activity in France.

BACKGROUND: The SARS-CoV-2 pandemic has majorly affected medical activity around the world. We sought to measure the impact of the COVID-19 pandemic on gastrointestinal (GI) endoscopy activity in France. METHODS: We performed a web-based survey, including 35 questions on the responders and their endoscopic practice, from 23 March to 27 March 2020, sent to the 3300 French gastroenterologists practicing endoscopy. RESULTS: 694 GI endoscopists (21 %) provided analyzable data; of these, 29.4 % (204/694) were involved in the management of COVID-19 patients outside the endoscopy department. During the study period, 98.7 % (685/694) of endoscopists had had to cancel procedures. There were 89 gastroenterologists (12.8 %) who reported symptoms compatible with COVID-19 infection, and a positive PCR test was recorded in 12/197 (6.1 %) vs. 3/497 (0.6 %) endoscopists in the high vs. low prevalence areas, respectively (P < 0.001). CONCLUSIONS: The COVID-19 pandemic led to a major reduction in the volume of GI endoscopies performed in France in March 2020. The prolonged limited access to GI endoscopy could lead to a delay in the management of patients with GI cancers.

Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: a prospective multicenter study.

BACKGROUND: Pancreatic neuroendocrine tumors (NETs) and intraductal pancreatic mucinous neoplasia (IPMN) with worrisome features are surgically managed. Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) has recently been developed. The safety of EUS-RFA was the primary end point of this study, its efficacy the secondary end point. METHODS: This was a prospective multicenter study that was planned to include 30 patients with a 1-year follow-up with either a NET < 2 cm or a pancreatic cystic neoplasm (PCN), either a branch duct IPMN with worrisome features or a mucinous cystadenoma (MCA). EUS-RFA was performed with an 18G RFA cooling needle. RESULTS: 12 patients had 14 NETs (mean size 13.1 mm, range 10 - 20 mm); 17 patients had cystic tumors (16 IPMNs, 1 MCA; mean size 28 mm, range 9 - 60 mm). Overall three adverse events occurred (10 %), two of these in the first two patients (one pancreatitis, one small-bowel perforation). After these initial patients, modifications in the protocol resulted in a decrease in complications (3.5 %), with one patient having a pancreatic ductal stenosis. Among the 14 NETs, at 1-year follow-up 12 had completely disappeared (86 % tumor resolution), with three patients having a delayed response. Among the 17 PCNs, at 12 months, there were 11 complete disappearances and one diameter that decreased by > 50 % (significant response rate 71 %). All 12 mural nodules showed complete resolution. CONCLUSIONS: EUS-RFA of pancreatic NETs or PCNs is safe with a 10 % complication rate, which can be decreased by improved prophylaxis for the procedure.

[Oesophagus polyps: Giant fibrovascular polyp of the oesophagus disappears!] / Polypes œsophagiens : le polype géant fibrovasculaire de l'œsophage n'existe plus !

The giant fibrovascular polyp of the esophagus is a rare, benign and typical entity described in 1957. This lesion is easily identifiable in its macroscopic and microscopic aspects. However, recent studies question the existence of the giant fibrovascular polyp of the esophagus. The demonstration of an amplification of the MDM2 gene poses the diagnosis of well-differentiated liposarcoma. We describe here a case of an esophagus polyp in a 67-year-old man. The diagnosis of giant fibrovascular polyp of the esophagus was initially retained. Secondly, the immunohistochemical and fluorescence in situ hybridization techniques showed amplification of the MDM2 gene and reclassified the lesion to a well-differentiated liposarcoma. The search for an undifferentiated contingent is essential to not ignore a dedifferentiated liposarcoma, which is a high-grade sarcoma with a poorer prognosis.

High Prevalence of Anal Canal High-Risk Human Papillomavirus Infection in Patients With Crohn's Disease.

BACKGROUND & AIMS: The increasing incidence of anal canal carcinomas requires better knowledge on anal human papillomavirus (HPV) infection. We aimed to assess anal canal HPV infection prevalence and risk factors among patients seen at a gastroenterology department in France. METHODS: We analyzed anal tissue samples collected from 469 consecutive patients (median age 54 years, 52% women), including 112 who received immunosuppressant therapies and 101 with inflammatory bowel disease (70 with Crohn's disease), who underwent colonoscopy examinations from April 1, 2012 to April 30, 2015. HPV was detected and genotyped using the INNO-LiPA assay, and we collected medical and demographic data from all subjects. Risk factors for any HPV, high-risk HPV (HR-HPV) and HPV16 infection were assessed by bivariate and multivariate analysis. The primary outcomes association of HR-HPV or HPV16 with medical and demographic features. RESULTS: We detected HPV DNA in anal tissues from 34% of the subjects and HR-HPV in 18%. HPV16 was the most prevalent genotype (detected in 7%), followed by HPV51, HPV52, and HPV39. HR-HPV was detected in a significantly higher proportion of samples from women (23.1%) than men (12.8%) (P = .0035); HR-HPV and HPV16 were detected in a significantly higher proportion of patients with Crohn's disease (30.0%) than without (18.1%) (P = .005). Female sex, history of sexually transmitted disease, lifetime and past year-number of sexual partners, active smoking, and immunosuppressive therapies were independent risk factors for anal HR-HPV infection in multivariate analysis. CONCLUSION: One third of patients who underwent colonoscopy at a gastroenterology department were found to have anal canal HPV infection. We detected HR-HPV infection in almost 20% of patients and in a significantly higher proportion of patients with Crohn's disease than without. Increasing our knowledge of HPV infection of anal tissues could help physicians identify populations at risk and promote prophylaxis with vaccination and adequate screening.

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study.

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).

Additive value of pre-operative and one-month post-operative lymphocyte count for death-risk stratification in patients with resectable pancreatic cancer: a multicentric study.

BACKGROUND: Pancreatic adenocarcinoma (PDAC) incidence is increasing worldwide. Several studies have shown that lymphopenia was correlated with a poor prognosis but the potential interest to measure lymphopenia in the pre and post-operative setting as well as its added value among conventional prognostic factors was never investigated. METHODS: Data from two independent cohorts in whom patients underwent resection for pancreatic carcinoma were retrospectively recorded. We examined the association between perioperative findings, pre and post-operative lymphocyte counts and overall survival (OS) in univariate and multivariate analyses. Performance assessment and internal validation of the final model were evaluated with Harrell's C-index, calibration plot and bootstrap sample procedures. RESULTS: Three hundred ninety patients were included in the analysis between 2000 and 2011. Pre and post-operative lymphocyte counts were independent prognostic factors associated with OS in multivariate analysis (p = 0.0128 and p = 0.0764, respectively). The addition of lymphocyte count variable to the conventional parameters identified in multivariate analysis (metastatic lymph node ratio, veinous emboli and adjuvant chemotherapy) significantly improved the model discrimination capacity (bootstrap mean difference = 0.04; 95 % CI, 0.01-0.06). The use of a threshold and combining the categorical (≥1000; <1000) information in pre and post lymphocyte counts permitted the identification of 4 subgroups of patients with different prognosis (p < 0.0001). Finally, the description of patients in long-term remission showed that only 3 of 65 (4.6 %) patients with post-operative lymphocyte count under 1000/mm3 were alive 4 years after surgery contrary to 54 of 236 (22.8 %) patients with a post-operative lymphocyte count above 1000/mm3. CONCLUSION: Pre and post-operative lymphopenia are independent prognostic factors for OS and they have an additive value regarding conventional prognostic factors for death-risk stratification and to predict long-term survival. Lymphopenia should be included as stratification factors in future clinical trial assessing overall survival in pancreatic cancer patients.

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).

Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study.

BACKGROUND AND STUDY AIMS: A new core biopsy needle for endoscopic ultrasound (EUS)-guided sampling has recently been developed. The aim of this prospective multicenter study was to compare this needle with a standard needle in patients with solid pancreatic masses. PATIENTS AND METHODS: Consecutive patients with solid pancreatic masses referred to 17 centers for EUS-guided sampling were included. Each patient had two passes with a standard 22G needle and a single pass with a 22G core needle performed in a randomized order. Samples from both needles were separately processed for liquid-based cytology and cell-block preparation and were assessed independently by two blinded expert pathologists. The primary endpoint was the accuracy of the detection of malignancy. The reference standard was based on further cytohistological analysis obtained under ultrasound or computed tomography scanning, endoscopic or surgical guidance, and/or by clinical follow-up with repeated imaging examinations for at least 12 months. The secondary endpoints were the rate of technical failure and the quality of the cytohistological samples obtained. RESULTS: Of the 80 patients included (49 men; mean age 67.1 ±â€Š11.1), 87.5 % had final malignant diagnoses (adenocarcinoma n = 62, 77.5 %). There was no difference between the needles in diagnostic accuracy (standard needle 92.5 % vs. core needle 90 %; P = 0.68) or technical failure. Both pathologists found the overall sample quality significantly better for the standard needle (expert 1, P = 0.009; expert 2, P = 0.002). CONCLUSIONS: The diagnostic accuracy of EUS sampling for solid pancreatic masses using standard and core needles seems comparable but with a better overall histological sample quality for the former. ClinicalTrial.gov identifier: NCT01479803.

Long-term outcomes of endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction.

BACKGROUND: Hepaticogastrostomy drainage through endoscopic ultrasound (EUS-HGS) has emerged in the 2010s as a new technique for biliary decompression in cases of endoscopic retrograde cholangiopancreatography (ERCP) failure for malignant biliary obstruction (MBO). Substantial technical and procedural progress in performing EUS-HGS has been achieved, allowing high technical and clinical success and an acceptable risk of adverse events in studies mainly focusing on short-term outcomes. However, the long-term effects of EUS-HGS and the risk of recurrent biliary obstruction (RBO) have not been fully evaluated. OBJECTIVES: To evaluate the long-term effects of EUS-HGS and the risk of RBO. METHODS: Data from 211 patients undergoing technically successful EUS-HGS in three academic centers were retrospectively collected. Clinical success, adverse events, RBO, and reinterventions were evaluated. RESULTS: In total, 198 patients underwent technically successful EUS-HGS for MBO. The median overall survival was 144 days [108, 2011] after the procedure. Mean patient age was 69.39 (12.91) years. The cause of MBO was pancreatic cancer (n = 98, 49.5%) followed by cholangiocarcinoma (n = 29, 14.6%). The location of MBO was distal in 27.6% of cases and proximal in 68.4%. Adverse events were observed during the follow-up in 65 patients (33%). On multivariate analysis, the use of partially covered self-expandable metal stents (PCSEMS) was associated with a lower risk of RBO (HR = 0.47 [0.24-0.95], p = 0.034). Additionally, patients with distal stenoses had a trend toward better stent patency (HR = 0.06[0-0.77], p = 0.031). RBO developed in 38 cases (19.1%) mainly due tumor ingrowth (36.8%) with a high success rate of endoscopic management. CONCLUSIONS: While RBO occurred in a notable proportion of patients, the primary cause of mortality was progression of the underlying malignancy rather than stent dysfunction. The efficiency of stents, particularly PCSEMS, and the high success rate of endoscopic management for RBO underscore the effectiveness and reliability of these treatments in managing biliary complications.

Ampullary tumors: French Intergroup Clinical Practice Guidelines for diagnosis, treatments and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, ACHBT, AFC, SFRO, RENAPE, SNFCP, AFEF, SFP, SFR).

BACKGROUND: Management of ampullary tumors (AT) is challenging because of a low level of scientific evidence. This document is a summary of the French intergroup guidelines regarding the management of AT, either adenoma (AA) or carcinoma (AC), published in July 2023, available on the website of the French Society of Gastroenterology (SNFGE) (www.tncd.org). METHODS: A collaborative work was conducted under the auspices of French medical, endoscopic, oncological and surgical societies involved in the management of AT. Recommendations are based on recent literature review and expert opinions and graded in three categories (A, B, C), according to quality of evidence. RESULTS: Accurate diagnosis of AT requires at least duodenoscopy and EUS. All patients should be discussed in multidisciplinary tumor board before treatment. Surveillance may only be proposed for small AA in familial adenomatous polyposis. For AA, endoscopic papillectomy is the preferred option only if R0 resection can be achieved. When not possible, surgical papillectomy should be considered. For AC beyond pT1a N0, pancreaticoduodenectomy is the procedure of choice. Adjuvant monochemotherapy (gemcitabine, 5FU) may be proposed. For aggressive tumors (pT3/T4, pN+, R1, poorly differentiated AC, pancreatobiliary differentiation) with high risk of recurrence, 6 months polychemotherapy (CAPOX/FOLFOX for the intestinal subtype and mFOLFIRINOX for the pancreatobiliary or the mixed subtype) may be a valid alternative. Clinical and radiological follow up is recommended for 5 years. CONCLUSIONS: These guidelines help to homogenize and highlight unmet needs in the management of AA and AC. Each individual case should be discussed by a multidisciplinary team.