Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial.

BACKGROUND AND STUDY AIMS: Cold snare polypectomy is an established method for the resection of small colorectal polyps; however, significant incomplete resection rates still leave room for improvement. We aimed to assess the efficacy of cold snare endoscopic mucosal resection (CS-EMR), compared with hot snare endoscopic mucosal resection (HS-EMR), for nonpedunculated polyps sized 6 - 10 mm. PATIENTS AND METHODS: This study was a dual-center, randomized, noninferiority trial. Consecutive adult patients with at least one nonpedunculated polyp sized 6 - 10 mm were enrolled. Eligible polyps were randomized (1:1) to be treated with either CS-EMR or HS-EMR. Both methods involved submucosal injection of a methylene blue-tinted normal saline solution. The primary noninferiority end point was histological eradication evaluated by postpolypectomy biopsies (noninferiority margin - 10 %). Secondary outcomes included occurrence of intraprocedural bleeding, clinically significant postprocedural bleeding, and perforation. RESULTS: Among 689 patients screened, 155 patients with 164 eligible polyps were included (CS-EMR n = 83, HS-EMR n = 81). The overall rate of histological complete resection was 92.8 % in the CS-EMR group and 96.3 % in the HS-EMR group (difference 3.5 %; 95 % confidence interval [CI] - 4.15 to 11.56), showing noninferiority of CS-EMR compared with HS-EMR. CS-EMR was shown to be noninferior both for polyps measuring 6 - 7 mm (CS-EMR 93.3 %; HS-EMR 100 %; 95 %CI - 7.95 to 21.3) and those of 8 - 10 mm (92.5 % vs. 94.7 %, respectively; 95 %CI - 7.91 to 13.16). Rates of intraprocedural bleeding were similar between the two groups (CS-EMR 3.6 %, HS-EMR 1.2 %; P  = 0.30). No clinically significant postprocedural bleeding or perforation occurred in either group. CONCLUSIONS: CS-EMR appears to be a valuable modification of the standard cold snare technique, obviating the need to use diathermy for nonpedunculated colorectal polyps sized 6 - 10 mm.

Endoscopic Grading and Sampling of Gastric Precancerous Lesions: A Comprehensive Literature Review.

Gastric cancer remains a disease with an ominous prognosis, while early gastric cancer has a good-to-excellent prognosis, with 5-year survival rates of up to 92.6% after successful endoscopic resection. In this context, the accurate identification of patients with established gastric precancerous lesions, namely chronic atrophic gastritis and intestinal metaplasia, is the first step in a stepwise approach to minimize cancer risk. Although current guidelines advocate for the execution of random biopsies to stage the extent and severity of gastritis/intestinal metaplasia, modern biopsy protocols are still imperfect as they have limited reproducibility and are susceptible to sampling error. The advent of novel imaging-enhancing modalities, i.e., high-definition with virtual chromoendoscopy (CE), has revolutionized the inspection of gastric mucosa, leading to an endoscopy-based staging strategy for the management of these premalignant changes in the stomach. Nowadays, the incorporation of CE-targeted biopsies in everyday clinical practice offers not only the robust detection of premalignant lesions but also an improvement in quality, by reducing missed diagnoses along with mean biopsies and, thus, the procedural costs and the environmental footprint. In this review, we summarize the recent evidence regarding the endoscopic grading and sampling of gastric precancerous lesions.

Simulated performance of flexible sigmoidoscopy-based screening for advanced neoplasia detection in a Greek population.

BACKGROUND: Flexible sigmoidoscopy (FS) is resource-conserving and may increase adherence to colorectal cancer (CRC) screening compared to total colonoscopy. We investigated the diagnostic performance of FS-based screening for advanced colorectal neoplasia (ACN), including advanced adenomatous neoplasms (AANs), advanced serrated lesions (ASLs) and CRCs. METHODS: Data from 2005 subjects undergoing average-risk screening colonoscopy in a single center in Greece were retrospectively reviewed. Sensitivities of FS-based screening for detecting AANs, ASLs, CRCs or any ACN were simulated on a per-lesion basis, assuming: 1) FS up to the sigmoid-descending junction (FS-1) or splenic flexure (FS-2); 2) colonoscopy referral criteria according to the 4 screening FS trials conducted in UK, Italy, Norway, and USA. RESULTS: Overall, 114 ACNs (93 AANs, 17 ASLs, 4 CRCs) were detected in 102 (5.1%) subjects. The overall sensitivities of FS-1 and FS-2 alone for the detection of any ACN were 41.2% and 54.4%, respectively. Assuming different colonoscopy referral criteria, the estimated sensitivities for any ACN ranged from 48.2-50.9% for FS-1 and 60.5-64% for FS-2. The overall sensitivities were lower for ASLs (FS-1: 35.3-41.2%, FS-2: 41.2-52.9%) compared to those observed for AANs (FS-1: 48.4-51.6%, FS-2: 62.4-66.7%). The difference was particularly pronounced in women, in whom all 4 criteria led equally to a very low sensitivity for ASLs (30%). CONCLUSIONS: Implementation of FS-based screening in Greek subjects would have led to the detection of 48-64% of all ACNs. An alarmingly low detection of ASLs among women may call for gender-specific colonoscopy referral strategies.

Seven-day genotypic resistance-guided triple Helicobacter pylori eradication therapy can be highly effective.

BACKGROUND: The efficacy and applicability of molecular testing to guide the selection of antibiotics in triple Helicobacter pylori (H. pylori) eradication regimens have not been reported. We tested a 7-day, genotypic resistance-guided triple H. pylori eradication therapy in a high-resistance setting. METHODS: Consecutive dyspeptic patients with H. pylori infection were prospectively enrolled. Genotypic resistances to clarithromycin (23SrRNA mutations) and fluoroquinolones (gyrA mutations) were determined from gastric biopsy specimens using a commercially available molecular assay (GenoTypeâ HelicoDR). A tailored genotypic resistance-guided 7-day triple therapy comprised esomeprazole, amoxicillin, and either clarithromycin (wild-type 23SrRNA), levofloxacin (23SrRNA mutated/wild-type gyrA) or rifabutin (both 23SrRNA/gyrA mutated). H. pylori eradication was confirmed by 13C-urea breath test. RESULTS: Of 148 subjects screened, 51 patients were enrolled (male/female: 27/24, mean age: 50.7±11.4 years, treatment-naïve/-experienced: 32/19). The molecular kit was easily implemented, allowing for rapid (within 24 h) and relatively inexpensive determination of H. pylori resistance (clarithromycin: 47.1%, fluoroquinolones: 15.7%, dual clarithromycin/fluoroquinolones: 7.8%). For patients who received clarithromycin-, levofloxacin- and rifabutin-containing triple therapy, the respective eradication rates were 24/27, 20/20, and 2/4 by intention-to-treat (ITT); and 24/24, 19/19 and 2/3 by per-protocol (PP) analysis. Overall eradication rates were 90.2% (95% confidence interval [CI] 77.8-96.3%) by ITT and 97.8% (95%CI 87-99.8%) by PP analysis, showing no significant difference between treatment-naïve and -experienced patients (ITT: 87.5% vs. 94.7%, P=0.64; PP: 96.4% vs. 100%, respectively, P=1.00). CONCLUSIONS: Regardless of prior treatment history, a genotypic resistance-guided 7-day triple therapy, based on a simple molecular assay, achieved a high H. pylori eradication rate.

A delayed onset of bowel activity after the start of conventional polyethylene glycol predicts inadequate colon cleansing before colonoscopy: A prospective observational study.

BACKGROUND: Evaluation of factors correlating with the quality of bowel preparation (QBP) is critical to ensure high-quality colonoscopy. OBJECTIVES: We sought to determine whether the time interval between the start of conventional polyethylene glycol (PEG) ingestion and the onset of bowel activity is predictive of QBP. METHODS: Consecutive adult outpatients attending colonoscopy were prospectively assessed. Data including demographics, medical history, time of starting/completion of PEG and time when bowel activity started were recorded. The QBP was assessed according to the Ottawa bowel preparation score (OBPS); inadequate QBP was OBPS ≥7. RESULTS: A total of 171 patients (92 males, mean age: 60.5 years) complying with preparation instructions were included. The median OBPS was 5 (range: 1-13) and 57 (33.3%) had inadequate QBP. The median interval between the initiation of PEG and the onset of bowel activity was 60 min (range: 9-300 min). Patients (n = 52, 30.4%) with a delayed (>90 min) onset of bowel activity had poorer QBP (p = 0.0001). In multivariate analysis, male gender (OR: 2.38, p = 0.03), the interval between the end of preparation and the start of colonoscopy (OR: 1.94, p = 0.02) and time to onset of bowel activity >90 min (OR: 3.38, p = 0.004) were predictive of inadequate QBP. CONCLUSION: The time interval between the initiation of PEG ingestion and the onset of bowel activity is predictive of the QBP. Our data support "on demand" intensification of bowel preparation in patients with a delayed onset of purgative response to PEG.

A New Electromagnetic Navigation System for Pedicle Screws Placement: A Human Cadaver Study at the Lumbar Spine.

INTRODUCTION: Technical developments for improving the safety and accuracy of pedicle screw placement play an increasingly important role in spine surgery. In addition to the standard techniques of free-hand placement and fluoroscopic navigation, the rate of complications is reduced by 3D fluoroscopy, cone-beam CT, intraoperative CT/MRI, and various other navigation techniques. Another important aspect that should be emphasized is the reduction of intraoperative radiation exposure for personnel and patient. The aim of this study was to investigate the accuracy of a new navigation system for the spine based on an electromagnetic field. MATERIAL AND METHOD: Twenty pedicle screws were placed in the lumbar spine of human cadavers using EMF navigation. Navigation was based on data from a preoperative thin-slice CT scan. The cadavers were positioned on a special field generator and the system was matched using a patient tracker on the spinous process. Navigation was conducted using especially developed instruments that can be tracked in the electromagnetic field. Another thin-slice CT scan was made postoperatively to assess the result. The evaluation included the position of the screws in the direction of trajectory and any injury to the surrounding cortical bone. The results were classified in 5 groups: grade 1: ideal screw position in the center of the pedicle with no cortical bone injury; grade 2: acceptable screw position, cortical bone injury with cortical penetration ≤ 2 mm; grade 3: cortical bone injury with cortical penetration 2,1-4 mm, grad 4: cortical bone injury with cortical penetration 4,1-6 mm, grade 5: cortical bone injury with cortical penetration >6 mm. RESULTS: The initial evaluation of the system showed good accuracy for the lumbar spine (65% grade 1, 20% grade 2, 15% grade 3, 0% grade 4, 0% grade 5). A comparison of the initial results with other navigation techniques in literature (CT navigation, 2D fluoroscopic navigation) shows that the accuracy of this system is comparable. CONCLUSION: EMF navigation offers a high accuracy in Pedicle screw placement with additional advantages compared to other techniques. The short set-up time and easy handling of EMF navigation should be emphasized. Additional advantages are the absence of intraoperative radiation exposure for the operator and surgical team in the current set-up and the operator's free mobility without interfering with navigation. Further studies with navigation at higher levels of the spine, larger numbers of cases and studies with control group are planned.

Bilateral spinal decompression of lumbar central stenosis with the full-endoscopic interlaminar versus microsurgical laminotomy technique: a prospective, randomized, controlled study.

BACKGROUND: Extensive decompression with laminectomy, where appropriate, is often still described as the method of choice when operating on degenerative lumbar spinal stenosis. Nonetheless, tissue-sparing procedures are becoming more common. Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation. One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control. This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis. OBJECTIVE: This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique (FI) with a conventional microsurgical laminotomy technique (MI). STUDY DESIGN: Prospective, randomized, controlled study. SETTINGS: 135 patients with microsurgical or full-endoscopic decompression were followed up for 2 years. Alongside general and specific parameters, the following measuring instruments were also used for the investigation: Visual Analog Scale (VAS), German version of the North American Spine Society Instrument (NASS), Oswestry Low-Back-Pain-Disability Questionnaire (ODI). RESULTS: Postoperatively 72 % of the patients no longer had leg pain or the pain was almost completely reduced and 21.2 % experienced occasional pain. The clinical results were the same in both groups. The rate of complications and revisions was significantly reduced in the FI Group. The full-endoscopic techniques brought advantages in the following areas: operation, complications, traumatization, rehabilitation. LIMITATIONS: Lack of placebo control group. CONCLUSIONS: The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention.

Navigation of pedicle screws in the thoracic spine with a new electromagnetic navigation system: a human cadaver study.

INTRODUCTION: Posterior stabilization of the spine is a standard procedure in spinal surgery. In addition to the standard techniques, several new techniques have been developed. The objective of this cadaveric study was to examine the accuracy of a new electromagnetic navigation system for instrumentation of pedicle screws in the spine. MATERIAL AND METHOD: Forty-eight pedicle screws were inserted in the thoracic spine of human cadavers using EMF navigation and instruments developed especially for electromagnetic navigation. The screw position was assessed postoperatively by a CT scan. RESULTS: The screws were classified into 3 groups: grade 1 = ideal position; grade 2 = cortical penetration <2 mm; grade 3 = cortical penetration ≥2 mm. The initial evaluation of the system showed satisfied positioning for the thoracic spine; 37 of 48 screws (77.1%, 95% confidence interval [62.7%, 88%]) were classified as group 1 or 2. DISCUSSION: The screw placement was satisfactory. The initial results show that there is room for improvement with some changes needed. The ease of use and short setup times should be pointed out. Instrumentation is achieved without restricting the operator's mobility during navigation. CONCLUSION: The results indicate a good placement technique for pedicle screws. Big advantages are the easy handling of the system.

Combined HLA-DR and -DQ disparity is associated with a stable course of ulcerative colitis after liver transplantation for primary sclerosing cholangitis.

Combined disparity of human leukocyte antigen (HLA)-DR and -DQ between mother and fetus is associated with less severe ulcerative colitis (UC) during pregnancy. We evaluated whether donor-recipient HLA disparity after liver transplantation (LT) affects UC in patients with primary sclerosing cholangitis (PSC). Sixty-nine consecutive patients with PSC underwent LT; all underwent colonoscopy before LT; 48 had UC before and 3 had de novo UC after LT. Clinical and laboratory data, activity and treatment of UC, post-LT cytomegalovirus infection, and disparity of HLA-A, -B, -DR, and -DQ for each donor-recipient pair were evaluated. Pre-LT quiescent UC was present in 26 patients. Post-LT UC activity was evaluated in 36 of 51 patients with UC who had not undergone pre-LT colectomy and who had >12 months' post-LT survival. Of these, 16 were stable, 17 had worsened, and 3 had de novo UC. Seven required colectomy (4 for dysplasia or cancer) after LT. Post-LT cytomegalovirus viremia was neither associated with worse UC activity (P = 0.58) nor de novo UC. Disparity with respect to HLA-A, -B, -DR, and -DQ was found in 58%, 27%, 44%, and 39% donor-recipient pairs, respectively. Post-LT UC course was similar with respect to single HLA disparity. However, disparity in none or only one HLA-DR or -DQ was significantly associated with worse activity compared with patients with disparity at both (65% vs. 0%, P = 0.009). Logistic regression found that the disparity for both -DR and -DQ was the only factor statistically significantly associated with post-LT UC activity. We conclude that disparity in both HLA-DR and -DQ between donor and recipient is associated with stable UC activity after LT.