Intrahepatic Cholangiocarcinoma and Hepatocellular Carcinoma: Real-life Data on Liver Disease, Treatment and Prognosis.

Background and Aims: Hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (iCCA) have common features and differences. This real-life study investigated their characteristics, treatment modalities, and prognoses. Methods: This retrospective comparative study was performed in 1,075 patients seen at one tertiary center between January 2008 and December 2020. Overall survival (OS) was estimated by the Kaplan-Meier method. Subclassification of iCCAs after histological and radiological review, and molecular profiling was performed. Results: HCCs patients were more likely to have early-stage disease than iCCA patients. iCCA patients were more likely to be female, especially those patients without cirrhosis (43% vs. 17%). Cirrhosis was prominent among HCC patients (89% vs. 34%), but no difference in underlying liver disease among cirrhotic patients was found. OS of HCC patients was 18.4 (95% CI: 6.4, 48.3) months, that of iCCA patients was 7.0 (95% CI: 3.4, 20.1) months. OS of Barcelona Clinic Liver Cancer C HCC patients was 7.8 (95% CI: 4.3, 14.2) months, that of advanced/metastatic iCCA patients was 8.5 (95% CI: 5.7, 12.3) months. In patients treated with sorafenib, OS was longer in HCC patients who received subsequent tyrosine kinase inhibitor therapies. No significant OS difference was found between iCCA patients with and without cirrhosis or according to histological subtype. A targetable molecular alteration was detected in 50% of the iCCA patients. Conclusions: In this French series, cirrhosis was common in iCCA, which showed etiological factors comparable to those of HCC, implying a distinct oncogenic pathway. Both entities had a dismal prognosis at advanced stages. However, systemic therapies sequencing in HCC and molecular profiling in iCCA offer new insights.

Evaluation of Antireflux Mucosectomy for Severe Gastroesophageal Reflux Disease: Medium-Term Results of a Pilot Study.

BACKGROUND: Antireflux mucosectomy, a new endoscopic treatment for gastroesophageal reflux disease, consists of endoscopic mucosal resection at the esophagogastric junction. This study aim was to evaluate the medium-term efficacy of the antireflux mucosectomy technique for patients with severe gastroesophageal reflux disease symptoms (proton pump inhibitor treatment-dependent or proton pump inhibitor treatment-resistant gastroesophageal reflux disease). METHODS: Between January 2017 and June 2018, 13 patients with severe gastroesophageal reflux disease without hiatal hernia, with positive pH reflux, were included in this monocentric prospective pilot study. The primary outcome was clinical success, defined by improvement evaluated by the Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire at 24 months. Secondary outcomes were technical success, decreased use of proton pump inhibitors, patient satisfaction, and adverse events. RESULTS: Thirteen patients [females = 8 (62%)], mean age 59 (range, 54-68), were included. The antireflux mucosectomy procedure had technical success in all patients. At 24 months, for 11 patients, gastroesophageal reflux disease symptoms were significantly improved, and mean gastroesophageal reflux disease score decreased from 33 (range, 26-42) to 3 (range, 0-7) (p = 0.001). Ninety-one percent (n = 10) of patients had a lower proton pump inhibitor intake at 24 months. One patient had 3 endoscopic balloon dilatations for EGJ stenosis, two patients had melena ten days after procedure, and seven patients had thoracic or abdominal pain. Patient's satisfaction at 24 months was 81%. CONCLUSIONS: In patients with severe gastroesophageal reflux disease, despite occurrence of several short-term adverse events, antireflux mucosectomy seemed effective in improving gastroesophageal reflux disease symptoms at 24 months. This trial is registered with ClinicalTrials: NCT03357809.

Identification of endoscopic predictors of biliary malignancy during digital cholangioscopy.

OBJECTIVES: Biliary brushings and biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP) have a low sensitivity for the diagnosis of malignant biliary strictures. While cholangioscopic analysis is useful, visual criteria have not yet been defined. The aim of this study was to identify visual criteria for the diagnosis of indeterminate biliary strictures (IDBS). METHODS: A multicenter study was conducted based on the analysis of cholangioscopic recordings of IBDS. Diagnostic criteria were identified in a study group and verified in a validation group. RESULTS: Four criteria were identified to be associated with malignancy, one negatively ("endobiliary material," odds ratio [OR] 0.62, 95% confidence interval [CI] 0.41-0.92) and three positively ("vascularized villous projections," OR 1.52, 95% CI 1.03-2.24; "twisted or dilated vessels," OR 2.18, 95% CI 1.47-3.24; and "dark color of the mucosa," OR 1.82, 95% CI 1.23-2.70). Between two playbacks, the mean (95% CI) sensitivity of the observer's visual diagnosis increased from 66.1% (60-72) to 73.8% (69-78) (P = 0.004); in the second playback, the kappa value for interobserver agreement ranged between 0.36 (color) and 0.56 (endobiliary material), with a significant improvement (P = 0.0031-0.0001) between the first and second playbacks. Blind assessment by endoscopists not involved in this study had a diagnostic accuracy of 73% (71.4-74.5). CONCLUSION: The four identified cholangioscopic features are easy to implement in clinical practice and have the potential to increase the level of diagnostic confidence during the workup of IDBS.

Comparison of cold biopsy forceps vs cold snare for diminutive colorectal polyp removal: A multicenter non-inferiority randomized controlled trial.

BACKGROUND: European guidelines recommends the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. We aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy. METHODS: We conducted a multicenter non-inferiority randomized controlled trial. After screening, 123 patients were prospectively included and 180 DCPs were removed by either CBF or CSP after randomization (1:1). The primary end-point was the histological complete resection rate defined by negative additional biopsies taken from the edge of the polypectomy ulcer site. RESULTS: Among DCPs, 121 (67.2%) adenomas or sessile serrated lesions were considered for the analysis. Polyps were 4 [1-5] mm in size, mostly flat (55.4%) and located in the proximal colon (44.6%). The en bloc resection rate was higher in the CSP group than the CBF group (91.7% vs. 42.6%, p < 0.001). The histological complete resection rate was comparable in the two groups (93.33% vs 90.16%; p = 0.527), even for polyps < 4 mm (91.30% vs 91.30%; p = 1). All specimens were retrieved and there was no difference in terms of procedure times and adverse events. Finally, univariate analysis did not identify any potential factor associated with complete resection rate. CONCLUSION: In this study, CSP was comparable to CBF for the removal of DCP. Therefore, CBF may be considered as an alternative technique for resection of DCP, together with CSP, ClinicalTrials.gov registry (NCT04727918).

Early double-guidewire versus repeated single-guidewire technique to facilitate selective bile duct cannulation: a randomized controlled trial.

BACKGROUND: During endoscopic retrograde cholangiopancreatography (ERCP), access to the common bile duct (CBD) can be problematic after unintentional insertion of the guidewire into the pancreatic duct. We conducted a prospective, randomized study in order to compare biliary cannulation success rates of early double-guidewire (EDG) and repeated single-guidewire (RSG) techniques in patients with inadvertent passage of the guidewire into the pancreatic duct. METHODS: Patients with a native papilla were randomly assigned to either the EDG or RSG groups after unintentional insertion of the guidewire into the pancreatic duct. The primary outcome was successful selective CBD cannulation within 10 minutes. The secondary outcomes were successful final selective bile duct cannulation, time to bile duct cannulation, and frequency of post-ERCP pancreatitis (PEP). RESULTS: 142 patients were randomized and selective bile duct cannulation was achieved in 57/68 patients (84 %) in the EDG group and in 37/74 patients (50 %) in the RSG group within 10 minutes (relative risk 1.34; 95 % confidence interval 1.08-6.18; P < 0.001). The overall final selective bile duct cannulation rate was 99.3 %. The time to access the CBD was shorter using the EDG technique (6.0 vs. 10.4 minutes; P = 0.002). Mild PEP was not observed more frequently in the EDG group than in the RSG group. CONCLUSION: The EDG technique significantly increased the success rate of biliary duct cannulation within 10 minutes compared with an RSG approach.

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study.

OBJECTIVES: A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study. METHODS: All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis. RESULTS: Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related. CONCLUSIONS: The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.

Long-term outcome after EUS-guided radiofrequency ablation: Prospective results in pancreatic neuroendocrine tumors and pancreatic cystic neoplasms.

Background and study aims Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for pancreatic neuroendocrine tumors (NETs) and intraductal pancreatic mucinous neoplasia (IPMN) with worrisome features or high-risk stigmata (WF/HRS) has been evaluated in few series with short-term outcomes. This study's primary endpoint was to assess the long-term efficacy of EUS-RFA in patients with NETs or pancreatic cystic neoplasms (PCNs) over at least 3 years. Patients and methods Twelve patients had 14 NETs with a mean 13.4-mm size (10-20) and 17 patients had a cystic tumor (16 IPMN, 1 MCA) with a 29.1-mm mean size (9-60 were included. They were treated with EUS-guided RFA, evaluated prospectively at 1 year, and followed annually for at least 3 years. Results The mean duration of follow-up was 42.9 months (36-53). Four patients died during follow-up (17-42 months) from unrelated diseases. At 1-year follow-up, and 85.7 % complete disappearance was seen in 12 patients with 14 NETs. At the end of follow-up (45.6 months), complete disappearance of tumors was seen in 85.7 % of cases. One case of late liver metastasis occurred in a patient with initial failure of EUS-RFA. At 1-year follow-up, a significant response was seen in 70.5 % of 15 patients with PCNs. At the end of the follow-up, there was a significant response in 66.6 % with no mural nodules. Two cases of distant pancreatic adenocarcinoma unrelated to IPMN occurred. Conclusions EUS-RFA results for pancreatic NETs or PCNs appear to be stable during 42 months of follow-up.

Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study.

OBJECTIVES: Peroralcholangio-pancreatoscopy (POCP) is used for diagnosis and treatment of biliopancreatic disease when standard endoscopy (ERCP) or pre-operative imaging workup failed. We aimed to evaluate the diagnostic and therapeutic performance of POCP in complex biliary and pancreatic diseases. MATERIALS AND METHODS: Patients with indeterminate biliary or pancreatic duct (PD) strictures, and patients with failure of complex biliary or pancreatic stones removal, were enrolled (six centers). The primary endpoint evaluated malignancy diagnostic performances (accuracy, sensitivity, specificity) and therapeutic performances (biliary or pancreatic stones extraction). Secondary endpoints evaluated: technical success in lesion visualization, ease of maneuvering, image quality and 30-days complications. RESULTS: From November 2016 to March 2018, 66 patients were included: 29/37 women/men, median age (IQR): 73 (64-82). Fifty-three patients had diagnostic POCP and 13 patients therapeutic POCP. One endoscopist with one or two endoscopy nurses performed 94% of the POCP. The 'POCP visual impression' of malignancy showed 92.0% sensitivity, 92.9 % specificity and 92.5 % overall accuracy compared with the final diagnosis. 'POCP-guided samples histological analysis' showed 75.0 % sensitivity and 91.6% specificity. The technical success for lesion visualization was 98.5%. The median VAS scores for insertions in bile and PD were respectively 9.0 (8.1-9.6) and 9.0 (8.8-10.0). Median VAS score for access to the lesion and image quality were respectively 9.0 (7.7-9.6) and 9.0 (7.9-9.7). Only three 30-day minor complications occurred without any major complications. CONCLUSIONS: POCP was an effective, safe and easy-to-use tool in routine clinical practice for the management of complex diagnostic and therapeutic biliary and pancreatic diseases (NCT03190343).

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.

Genomic profile concordance between pancreatic cyst fluid and neoplastic tissue.

BACKGROUND: DNA mutational analysis of pancreatic cystic fluid (CF) is a useful adjunct to the evaluation of pancreatic cysts. KRAS/GNAS or RAF/PTPRD/CTNNB1/RNF43 mutations are highly specific to precancerous or advanced neoplasia. Several studies recently demonstrated the ability of next-generation sequencing (NGS) analysis to detect DNA mutations in pancreatic CF, but few studies have performed a systematic comparative analysis between pancreatic CF and neoplastic surgical tissue (NT). The value of CF-NGS analysis indicators for determining surgical resection necessitates evaluation. AIM: To confirm whether CF genomic profiles are a reliable malignancy predictor by comparing NGS mutational analyses of CF and NT. METHODS: Patients requiring surgery for high-risk pancreatic cysts were included in a multicenter prospective pilot study. DNA from CF (collected by endoscopic ultrasound-guided fine needle aspiration (known as EUS-FNA)) and NT (collected by surgery) were analyzed by NGS. The primary objective was to compare the mutation profiles of paired DNA samples. The secondary objective was to correlate the presence of specific mutations (KRAS/GNAS, RAF/ PTPRD/CTNNB1/RNF43/POLD1/TP53) with a final cancer diagnosis. Sensitivity and specificity were also evaluated. RESULTS: Between December 2016 and October 2017, 20 patients were included in this pilot study. Surgery was delayed for 3 patients. Concordant CF-NT genotypes were found in 15/17 paired DNA, with a higher proportion of mutated alleles in CF than in NT. NGS was possible for all pancreatic CF collected by EUS-FNA. In 2 cases, the presence of a KRAS/GNAS mutation was discordant between CF and NT. No mutations were found in 3 patients with NT or pancreatic cysts with high-grade dysplasia. The sensitivity and specificity of KRAS/GNAS mutations in CF to predict an appropriate indication for surgical resection were 0.78 and 0.62, respectively. The sensitivity and specificity of RAF/PTPRD/CTNNB1 /RNF43/POLD1/TP53 mutations in CF were 0.55 and 1.0, respectively. CONCLUSION: Mutational analyses of CF and NT were highly concordant, confirming the value of NGS analysis of CF in the preoperative malignancy assessment. However, these results need to be confirmed on a larger scale.

Impact of peroral cholangioscopy on the management of indeterminate biliary conditions: a multicentre prospective trial.

BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) can help diagnose biliopancreatic conditions. The impact of SOC on patient outcome has never been specifically addressed. PATIENTS AND METHODS: Consecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included. Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology. Primary endpoint was the difference in adequacy of management planned before and after SOC with regard to final diagnosis obtained after surgery or 24 months follow-up. DESIGN: Prospective open-label multicentre trial. RESULTS: 61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6%). The management adequacy rate was significantly higher after SOC than before SOC overall (p<10-5), in IDBS (p<0.001) and PSC (p<0.05) patients. SOC induced changes in the management of the majority of patients in all groups (60.3%). The overall sensitivity of combined visual impression and biopsy ranged from 52% to 63.6% depending on investigator or independent expert rating (κ 0.92-0.96), whereas specificity, positive and negative predictive values of SOC were, respectively, 100%, 100% and 83.6%. Patient management observed at the end of follow-up was consistent with that anticipated after SOC in 88.5% overall. CONCLUSION: Despite a moderate sensitivity for the diagnosis of malignancy, SOC has a dramatic impact on the management of patients with IDBS and PSC with suspected carcinoma. Cholangioscopy might be implemented in the workup of selected patients with challenging diagnosis, when a significant impact on outcome (essentially resection vs conservative management) is to be expected.

19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.

BACKGROUND: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors. METHODS: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed. RESULTS: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively (P = 0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4 % (95 %CI 66.9 % - 90.2 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %; P = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % - 100 %) vs. 86.4 % (95 %CI 75.0 % - 94.0 %), respectively (P = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 - 0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.

Comparative evaluation of two porcine ex vivo models for training in endoscopic ultrasound-guided drainage of pancreatic fluid collections.

INTRODUCTION: EUS-guided cystoenterostomy (EUCE), a technique used for the drainage of pancreatic pseudocysts and peri-enteric collections, requires specific skills for which dedicated models are needed. Based on a compact EASIE model (Erlangen Active Simulator for Interventional Endoscopy), we developed two ex vivo porcine models of retrogastric cysts and evaluated learning performance within the frame of a structured training program. MATERIAL AND METHODS: The first model was made of porcine colon (i. e. "natural cyst"), the second one with an ostomy bag (i. e. "artificial cyst"). All procedures were achieved with an EUS scope under fluoroscopy. Both models were evaluated prospectively over a 2-day session involving 14 students and five experts. The primary end point was overall satisfaction with each model. RESULTS: The "natural cyst" and "artificial cyst" were prepared within 10 and 16.5 minutes ( P  = 0.78), respectively. Model grading showed a non-significant trend for overall satisfaction in favor of the artificial model ( P  = 0.06). As secondary end points, difference was not significant for impression of realism ( P  = 0.75) whereas the "artificial cyst" was graded significantly better by experts and students in terms of ability to teach procedural steps ( P  = 0.01) and ease of puncture ( P  = 0.03). Moreover, experts considered the ability to improve students' proficiency to be superior with the "artificial cyst" ( P  = 0.008). CONCLUSION: Both "artificial" and "natural cysts" are efficient for EUCE training in terms of overall satisfaction. However, the "artificial cyst" model appears to make the procedure easier with a higher ability to teach procedural steps and improve the students' proficiency. Larger applications of this model are needed to validate as a standard of training.

Double guidewire endoscopic technique, a major evolution in endoscopic retrograde cholangiopancreatography: Results of a retrospective study with historical controls comparing two therapeutic sequential strategies.

BACKGROUND AND AIM: Endoscopic access to the common bile duct (CBD) remains difficult in 10% of cases, requiring alternative techniques .CBD access was difficult after either five unsuccessful attempts, five unintentional insertions into the pancreatic duct or >10-min-long unsuccessful attempts. This retrospective study with historical controls aimed to evaluate the benefit of the double guidewire (DGW) technique after failure of standard CBD cannulation. METHODS: From January 2012 to December 2014, all patients requiring therapeutic endoscopic retrograde cholangiopancreatography (ERCP) with difficult access to CBD were included in a Studied group. This group was compared to a historical ERCP control group from January 2009 to December 2011. In the Studied group, a sequential strategy including DGW technique was done when the guidewire was unintentionally passed into the pancreatic duct. In the control group, only pre-cut technique was used. RESULTS: Among the 538 patients with naive papilla eligible for ERCP, 73 had difficult CBD access. Successful CBD access rate was higher in the Studied group: 91% (50/55) versus 67% (12/18) P = 0.0215. Complication rates were similar in both groups: 28% versus 20%, P = 0.5207. LOS was shorter in the Studied group (9.2 ± 8.5 vs 14.4 ± 7.4 days, P = 0.0028). Post-ERCP cholangitis were lower in the Studied group: 2% (1/55) versus 22% (4/18), P = 0.0118. CONCLUSION: After standard cannulation failure, DGW technique increased successful CBD access rate and decreased LOS without increasing complications.

Pneumatic dilation for achalasia in a patient with esophageal varices.

BACKGROUND AND STUDY AIMS: Previous reports of simultaneous presence of esophageal varices (EV) and achalasia suggest placement of a transjugular intrahepatic portosystemic shunt (TIPS) and surgical myotomy or endoscopic therapy. We report the case of a 64-year-old man who received anticoagulant therapy for a myeloproliferative disorder with extensive portal thrombosis which was a contraindication to placement of a TIPS. .

Endoscopic submucosal dissection for superficial rectal tumors: prospective evaluation in France.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) provides a high en bloc resection rate for superficial colorectal tumors. The aims of this study were to assess the feasibility of ESD in France and to evaluate the complete resection rate at 1 year. PATIENTS AND METHODS: Patients with superficial rectal tumors ≥ 10 mm in size were prospectively included in the study at nine French expert centers between February 2010 and June 2012. The study was stopped temporarily because of a high complication rate. Study recruitment resumed following remedial action. RESULTS: A total of 45 patients were included (mean age 67 years; 24 males). The immediate perforation rate was 18 % (n = 8), and salvage surgery was not required. Six patients (13 %) had late bleeding, which was treated endoscopically in five patients and surgically in one patient who had required blood transfusion. The mortality rate was zero. The en bloc resection rate was 64 % (29/45), and the curative R0 resection rate was 53 % (24/45). Three patients (7 %) had an invasive tumor (two sm1, one T2). At 1-year follow-up, endoscopic examinations showed complete resection in 38 /43 patients (88 %). At the end of the study, after the remedial action, the en bloc resection rate had increased from 52 % to 82 %, and the perforation rate had decreased significantly from 34 % to 0 %. CONCLUSIONS: The study reflects the initial prospective experience of ESD in France, and suggests that curative R0 resection rates should increase and complication rates should decrease with experience and corrective actions.

A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy.

BACKGROUND: Endoscopist-administered propofol sedation for colonoscopy has not been compared to anaesthetist-administered deep sedation in clinical trials. Our aim was to compare patients' satisfaction and safety during these two sedation modalities. METHODS: 90 adult patients undergoing colonoscopy were randomized into Group A, Endoscopist-administered propofol sedation and Group B, anaesthetist-administered deep sedation. Group A patients received an initial dose of 30-50 mg of intravenous propofol; additional doses were injected by the endoscopist using a pre-programmed pump. Global satisfaction was measured on a 0-100 mm visual analogue scale. RESULTS: The average satisfaction scores after examination completion amongst group were not statistically different (90.8 mm for Group A vs. 89 mm for Group B). Group A patients expressed more frequently a good level of satisfaction (95% vs. 75%; p=0.03) and willingness to undergo further colonoscopies under the same conditions (95% vs. 79%; p=0.02). Total duration time and procedural difficulty did not differ between the groups. Group A received a lower total propofol dose than Group B (94 mg vs. 260 mg) and experienced fewer side-effects (16 vs. 3, respectively; p < 0.008). CONCLUSION: Endoscopist-administered propofol sedation for colonoscopy offered a better level of satisfaction and fewer side-effects than anaesthetist-administered deep sedation.

[Anasarca, a complication of chemotherapy with gemcitabine in two patients with pancreatic cancer]. / L'anasarque: une complication du traitement par la gemcitabine chez deux malades porteurs d'un cancer du pancréas.

Pancreatic adenocarcinoma is the fifth most common cause of cancer-related mortality in the world. The nucleoside analogue gemcitabine is the established standard therapy for advanced disease. Rare cases of gemcitabine-associated systemic capillary leak syndrome have been reported. Here, we present two cases of capillary-leak syndrome in patients with pancreatic cancer treated with gemcitabine.