Mihai Rimbaş

Trainee caseload correlates with ERCP success rates but not with procedure-related complications: results from a prospective study (the QUASIE cohort)

Background and study aim: Endoscopy society guidelines recommend a minimum of 200 cases for endoscopic retrograde cholangiopancreatography (ERCP) trainees in order to ensure competency and quality standards. However, there are few data regarding procedure-related complication rates and added risk for patients during this learning process. We aimed to evaluate the correlation between trainee caseload and procedure- and patient-related outcomes in an ERCP training program, and to assess the risk factors for ERCP failure and complications. Patients and methods: We conducted a prospective study of all procedures performed in the ERCP training program at Colentina Clinical Hospital, Bucharest, Romania. Relevant data for each procedure (diagnosis, cannulation method, outcome, and complications during the following 30 days) as well as operator experience were documented. Univariable and multivariable analysis of the risk factors for ERCP failure and complications was done by analyzing the procedures completed by expert and trainee endoscopists during the study period. Results: The analysis included 534 ERCPs performed by 1 expert and 3 supervised trainees during a 12-month period. Technical success rates were comparable in the trainee and expert groups, and no statistically significant difference was found between the two groups with regard to procedure-related complications and mortality. The more experienced trainees had a better chance of successfully completing a procedure (odds ratio of 1.1 for each additional 10 ERCPs performed), but post-ERCP complications were unrelated to individual trainee caseloads on multivariable analysis. Conclusion: The ERCP technical success rate increases with trainee experience, reflecting the learning curve of individual operators. However, the complication rates are similar across different levels of operator experience, indicating that ERCPs performed by supervised trainees imply no additional risk for patients.

Ferritin above 100 mcg/L could rule out colon cancer, but not gastric or rectal cancer in patients with involuntary weight loss

BackgroundA tenth of patients with involuntary weight loss (IWL) have gastrointestinal cancer. Ferritin is the first parameter to be modified during the process leading to iron deficiency anaemia, therefore it should be the most sensitive. The aim of this study was to assess the ability of ferritin to rule out gastrointestinal cancer in patients with involuntary weight loss.MethodsAll consecutive patients with IWL admitted in a secondary care university hospital were prospectively studied. Ferritin, haemoglobin with erythrocyte indices and serum iron were recorded for all patients. The reference standard was bidirectional endoscopy and/or 6 months follow-up.Results290 patients were included, a quarter had cancer, of which 22 (7.6%) had gastrointestinal cancer (8 gastric cancer, 1 ileum cancer, 13 colorectal cancer). Ferritin had the best area under the curve (AUC), both for gastrointestinal cancer (0.746, CI: 0.691-0.794), and colorectal cancer (0.765, CI: 0.713-0.813), compared to the other parameters of iron deficiency. In the diagnosis of colorectal cancer, ferritin with a cut-off value of 100 mcg/L had a sensitivity of 93% (CI: 69-100%), and negative likelihood ratio of 0.13, with a negative predictive value of 99% (96-100%), while for gastrointestinal cancer, the sensitivity was lower (89%, CI: 67-95%), with a negative likelihood ratio of 0.24. There were three false negative patients, two with gastric cancer, and one with rectal cancer.ConclusionIn patients with involuntary weight loss, a ferritin above 100mcg/L could rule out colon cancer, but not gastric or rectal cancer.

NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients

AIM To investigate the small bowel of seronegative spondyloarthropathy (SpA) patients in order to ascertain the presence of mucosal lesions. METHODS Between January 2008 and June 2010, 54 consecutive patients were enrolled and submitted to a video capsule endoscopy (VCE) examination. History and demographic data were taken, as well as the history of non-steroidal anti-inflammatory drug (NSAID) consumption. After reading each VCE recording, a capsule endoscopy scoring index for small bowel mucosal inflammatory change (Lewis score) was calculated. Statistical analysis of the data was performed. RESULTS The Lewis score for the whole cohort was 397.73. It was higher in the NSAID consumption subgroup (P = 0.036). The difference in Lewis score between NSAID users and non-users was reproduced for the first and second proximal tertiles of the small bowel, but not for its distal third (P values of 0.036, 0.001 and 0.18, respectively). There was no statistical significant difference between the groups with regard to age or sex of the patients. CONCLUSION The intestinal inflammatory involvement of SpA patients is more prominent in NSAID users for the proximal/mid small bowel, but not for its distal part.

Is virtual chromoendoscopy useful in the evaluation of subtle ulcerative small-bowel lesions detected by video capsule endoscopy?

Background: The identification of subtle small-bowel mucosal lesions by video capsule endoscopy (VCE) can be challenging. Virtual chromoendoscopy techniques, based on narrowing the bandwidth of conventional white light endoscopic imaging (WLI), were developed to improve the analysis of mucosal patterns. However, data on the already-implemented Flexible spectral Imaging (or Fujinon Intelligent) Color Enhancement (FICE) software application in VCE are limited. Materials and methods: An evaluation of 250 difficult-to-interpret small-bowel ulcerative and 50 artifact lesions selected from 64 VCE recordings was conducted by four experienced VCE readers in two steps: initially as WLI, then with the addition of all available virtual chromoendoscopy pre-sets (FICE 1, 2, and 3 and Blue mode). The readers labeled them as real or false ulcerative lesions and rated the usefulness of each of the pre-sets. Results: Between the first (WLI-only) and second (virtual chromoendoscopy-aided) readings, in terms of accuracy there was a global 16.5 % (95 % confidence interval [95 %CI] 13.6 – 19.4 %) improvement (P < 0.001), derived from a 22 % [95 %CI 18.9 – 25.1 %] improvement in the evaluation of true ulcerative images (P < 0.001) and an 11 % (95 %CI 4.1 – 17.7 %) decrease in the evaluation of false ulcerative ones (P = 0.003). The FICE 1 and 2 pre-sets were rated as most useful. Conclusion: The application of virtual chromoendoscopy for VCE is useful to better categorize difficult-to-interpret small-bowel mucosal ulcerative lesions. However, care must be taken, and individual images should be evaluated only as part of a sequence in a recording because the technology can also mistakenly guide to the incorrect interpretation of artifacts as ulcerative lesions.

Cancer and involuntary weight loss: failure to validate a prediction score.

Background Many patients who have involuntary weight loss have cancer. The Hernandez prediction rule includes 5 variables (elevated levels of alkaline phosphatase and lactate dehydrogenase, low albumin, high white blood cell count, and age >80 years). The purpose of this study was to evaluate the validity of the prediction rule. Methods We prospectively evaluated 290 consecutive inpatients and outpatients who had involuntary weight loss. Clinical, hematologic, and biochemical parameters were determined. There were 259 patients who had follow-up at 6 months to determine the cause of involuntary weight loss, and 31 other patients were lost to follow-up. The 5 variables were introduced into a regression logistic model with cancer as a dependent variable. Results Cancer was diagnosed in 72 of the 290 patients (25%) who had involuntary weight loss. Bivariate analysis showed that serum albumin, C-reactive protein, erythrocyte sedimentation rate, alkaline phosphatase, iron, lactate dehydrogenase, white blood cell count, hemoglobin, and ferritin levels were associated with cancer (range of area under the receiver operating characteristic curve, 0.589 to 0.688). Multivariate analysis showed that albumin, erythrocyte sedimentation rate, iron, white blood cell count, and lactate dehydrogenase levels were associated with cancer. When dichotomized, only low albumin (odds ratio, 2.6, CI [1.3–5.2]) and high alkaline phosphatase (odds ratio, 2.3, CI [1.7–4.7]) were associated with cancer. The area under the receiver operating characteristic curve of the 5-variable prediction rule was only 0.70 (95% confidence interval, 0.61–0.78). The negative predictive value of this model with 3 variables (age >60 y, alkaline phosphatase, and albumin level) increased from 85% to 95% when all tests were negative. Conclusions In patients who had involuntary weight loss, those who have cancer are likely to have ≥1 abnormal laboratory test. The 5-variable prediction rule had a significantly lower accuracy than originally reported. Further evaluation of the 3-variable modification of the prediction rule may be useful.

Performance of a new needle for endoscopic ultrasound-guided fine-needle biopsy in patients with pancreatic solid lesions: A retrospective multicenter study

Background and Objectives: Procurement of tissue core biopsy samples may overcome some of the limitations of endoscopic ultrasound (EUS)-guided fine-needle aspiration. We aimed at assessing the safety, histological sample procurement yield, and diagnostic accuracy of a newly available histology needle. Materials and Methods: Data from consecutive patients with pancreatic solid lesions who underwent EUS-fine needle biopsy (EUS-FNB) using the 22-gauge Acquire™ needle were retrospectively retrieved from four tertiary care centers database. Results: Fifty-nine patients (mean age 68 ± 12 years; male/female 29/30) with pancreatic solid lesions underwent EUS-FNB using the 22-gauge Acquire™ needle. The biopsy was done transgastrically in 22 (37.3%) patients and transduodenally in 37 (62.7%) cases. A mean of 2.8 ± 0.45 needle passes per lesion site were performed, without any major complication. A tissue core biopsy sample for histological evaluation was obtained in 55 (93.2%) cases. In the additional four cases, the specimen obtained resulted adequate for cytological evaluation. Considering malignant versus nonmalignant disease, sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, and diagnostic accuracy were 98.2% (95% confidence interval [CI], 90.6–99.7), 100% (95% CI, 43.6–100), 0.018 (95% CI, 0.003–0.125), 295.6 (95% CI, 0–9.3 × 1010), and 98.3% (95% CI, 94.9–100), respectively. Conclusions: EUS-FNB using the 22-gauge Acquire™ needle is able to reach a very high procurement yield and diagnostic accuracy. Large prospective studies are warranted to further evaluate the utility of this newly developed needle.

Different effects of anti-TNF-alpha biologic drugs on the small bowel macroscopic inflammation in patients with ankylosing spondylitis.

Abstract Background & Aims. Considering the ability of anti-TNF alpha drugs to lower the burden intestinal inflammation in patients with inflammatory bowel disease (IBD), and the similarity between IBD and ankylosing spondylitis (AS) regarding inflammatory intestinal involvement, we aimed to investigate the impact of anti-TNF alpha biologic therapy on subclinical intestinal inflammation in AS patients. Methods. Between January 2008 and December 2013, 38 AS patients and 23 controls were enrolled in the study and investigated with small bowel videocapsule endoscopy examination and ileocolonoscopy. Each tertile of the small bowel (proximal, mid and distal) was assessed by calculating the Lewis score based on the image stream. Results. The Lewis scores were significantly higher in the AS group compared to controls (580.9 ± 818 vs. 81 ± 121, p<0.001). 16 patients (42.1%) were on anti-TNF alpha therapy (Adalimumab (n = 5), Infliximab (n = 5) or Etanercept (n = 6)).31.3% of them used NSAIDs simultaneously, compared with 77.3% of the other patients (p<0.01). Their Lewis scores were lower compared to the other patients for the entire small bowel (306 ± 164 vs. 790 ± 1038, p = 0.015), its proximal and distal tertiles (238 ± 154 vs. 560 ± 543, p = 0.021, and 140 ± 189 vs. 300 ± 220, p = 0.027, respectively). The Lewis score was also lower in patients receiving Adalimumab/Infliximab compared to those on Etanercept for the entire bowel and its distal tertile (262 ± 165 vs. 380 ± 148, p = 0.069 and 62 ± 101 vs. 273 ± 236, p = 0.060, respectively). Conclusion. Anti-TNF alpha therapy in patients with AS reduces the subclinical intestinal inflammation, but the magnitude seems to depend upon the class anti-TNF alpha agent used (Clinical Trials. gov NCT00768950).

EUS-guided biliary drainage: Is it ready for prime time?

Endoscopic retrograde cholangiopancreatography (ERCP) currently represents the procedure of choice to achieve biliary drainage (BD) in patients with obstruction of the biliary tree by various etiologies. However, even in experts hands in about 3%–10% of cases, the procedure is not technically feasible due to surgically altered anatomy, gastric outlet obstructions, periampullary diverticula, or complete ductal obstructions.[1‐3] In such cases, percutaneous transhepatic biliary drainage (PTBD) is performed, which is associated with considerable morbidity (in up to 30% of cases), also causing significant discomfort to the patient because of the presence of the percutaneous drain and the need for reinterventions.[4,5]

An atypical type I gastric neuroendocrine tumor

Abstract Background. Gastric neuroendocrine tumors (GI-NETs) are rare lesions, usually discovered incidentally during endoscopy. Based on their pathology, there are 4 types of GI-NETs. Type I are multiple small polypoid lesions with central ulceration located in the gastric body or the fundus, associated with atrophic gastritis usually noninvasive and very rarely metastatic. We report on a rare case of a gastric NET arising from the muscularis propria layer of the pyloric ring. Case report. We present the case of a 65-year old woman with a history of alcoholic cirrhosis, investigated for melena. Upper endoscopy revealed a 30 mm submucosal pedunculated polypoid lesion located on the pylorus protruding in the duodenum, with normal overlying mucosa, fundic gastric atrophy and multiple small polyps at this level, with no active bleeding. CT scan did not reveal any distant metastases. An ultrasound endoscopy was performed, and a round hypoechoic heterogeneous solitary mass, evolving from the pyloric muscle was described. Considering a 30-mm tumor evolving from the gastric muscle layer in the absence of local invasion and with no distant metastases we decided against an endoscopical resection and we referred the patient to surgery. A laparoscopic wedge resection was performed. The pathology report described a 30/25 mm welldifferentiated neuroendocrine tumor invasive in the muscularis mucosa (pT3). Conclusions. Usually, type I neuroendocrine tumors are located in the body or the fundus of the stomach without submucosal invasion. The interesting feature in our case was that the tumor originated from the pylorus, making it an atypical presentation for a neuroendocrine tumor.

Low diagnostic yield of transduodenal endoscopic ultrasound-guided fine needle biopsy using the 19-gauge Flex needle: A large multicenter prospective study

Background and Objectives: Previous limited experiences have reported the 19-gauge flexible needle to be highly effective in performing endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for transduodenal lesions. We designed a large multicenter prospective study with the aim at evaluating the performance of this newly developed needle. Patients and Methods: Consecutive patients with solid lesions who needed to undergo EUS sampling from the duodenum were enrolled in 6 tertiary care referral centers. Puncture of the lesion was performed with the 19-gauge flexible needle (Expect™ and Slimline Expect™ 19 Flex). The feasibility, procurement yield, and diagnostic accuracy were evaluated. Results: Totally, 246 patients (144 males, mean age 65.1 ± 12.7 years) with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were enrolled, with a mean size of 32.6 ± 12.2 mm. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%. Two centers had suboptimal procurement yields (66.7% and 64.2%). Major complications occurred in six cases: two of bleeding, two of mild acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma. Considering malignant versus nonmalignant disease, the sensitivity, specificity, positive/negative likelihood ratios, and diagnostic accuracy were 70.7% (95% confidence interval [CI]: 64.3–76.6), 100% (95% CI: 79.6–100), 35.3 (95% CI: 2.3–549.8)/0.3 (95% CI: 0.2–0.4), and 73.6% (95% CI: 67.6–79). On multivariate analysis, the only determinant of successful EUS-FNB was the center in which the procedure was performed. Conclusions: Our results suggest that the use of the 19-gauge flexible needle cannot be widely advocated and its implementation should receive local validation after careful evaluation of both the technical success rates and diagnostic yield.