To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas.
From 02-2009 to ...10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula.
In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life-threatening upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%).
This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.
ObjectiveAcute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or ...recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients.DesignWe conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding.Results246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362).ConclusionOTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis.Trial registration number NCT03331224.
Purpose
To assess the esophagogastric junction (EGJ) on real-time MRI and compare imaging parameters to EGJ morphology on high-resolution manometry (HRM).
Methods
A total of 105 of 117 eligible ...patients who underwent real-time MRI and high-resolution manometry for GERD-like symptoms between 2015 and 2018 at a single center were retrospectively evaluated (male
n
= 57; female
n
= 48; mean age 52.5 ± 15.4 years). Real-time MRI was performed at a median investigation time of 15 min (1 frame/40 ms). On HRM, EGJ morphology was assessed according to the Chicago classification of esophageal motility disorders. Real-time MRI was performed at 3 T using highly undersampled radial fast low-angle shot acquisitions with NLINV image reconstruction. A 10 mL pineapple juice bolus served as oral contrast agent at supine position. Real-time MRI films of the EGJ were acquired during swallowing events and during Valsalva maneuver. Anatomic and functional MRI parameters were compared to EGJ morphology on HRM.
Results
On HRM,
n
= 42 patients presented with EGJ type I (40.0%),
n
= 33 with EGJ type II (31.4%), and
n
= 30 with EGJ type III (28.6%). On real-time MRI, hiatal hernia was more common in patients with EGJ type III (66.7%) than in patients with EGJ type I (26.2%) and EGJ type II (30.3%;
p
< 0.001). Sliding hiatal hernia was more frequent in patients with EGJ type II (33.3%) than in patients with EGJ type III (16.7%) and EGJ type I (7.1%;
p
= 0.017). The mean esophagus–fundus angle of patients was 85 ± 31° at rest and increased to 101 ± 36° during Valsalva maneuver.
Conclusion
Real-time MRI is a non-invasive imaging method for assessment of the esophagogastric junction. Real-time MRI can visualize dynamic changes of the EGJ during swallowing events.
This study aims to develop a standardized algorithm for gastroesophageal image acquisition and diagnostic assessment using real-time MRI. Patients with GERD symptoms undergoing real-time MRI of the ...esophagus and esophagogastric junction between 2015 and 2018 were included. A 10 ml bolus of pineapple juice served as an oral contrast agent. Patients performed Valsalva maneuver to provoke reflux and hiatal hernia. Systematic MRI assessment included visual presence of achalasia, fundoplication failure in patients with previous surgical fundoplication, gastroesophageal reflux, and hiatal hernia. A total of 184 patients (n = 92 female 50%, mean age 52.7 ± 15.8 years) completed MRI studies without adverse events at a mean examination time of 15 min. Gastroesophageal reflux was evident in n = 117 (63.6%), hiatal hernia in n = 95 (52.5%), and achalasia in 4 patients (2.2%). Hiatal hernia was observed more frequently in patients with reflux at rest (n = 67 vs. n = 6, p < 0.01) and during Valsalva maneuver (n = 87 vs. n = 8, p < 0.01). Real-time MRI visualized a morphologic correlate for recurring GERD symptoms in 20/22 patients (90%) after fundoplication procedure. In a large-scale single-center cohort of patients with GERD symptoms undergoing real-time MRI, visual correlates for clinical symptoms were evident in most cases. The proposed assessment algorithm could aid in wider-spread utilization of real-time MRI and provides a comprehensive approach to this novel imaging modality.
Background and aims
A new external additional working channel (AWC) was recently introduced by which endoscopic submucosal dissection (ESD) can be converted to a technique termed “ESD+ ”. We aim to ...systematically evaluate this novel technique in flat gastric lesions and compare it to classical ESD.
Methods
The study was prospectively conducted in a pre-clinical ex vivo animal model (EASIE-R simulator) with porcine stomachs. Prior to intervention, we set standardized lesions measuring 3 cm or 4 cm in antegrade as well as in retrograde positions.
Results
Overall, 64 procedures were performed by an experienced endoscopist. Both techniques were reliable and showed en bloc resection rates of 100%. Overall, ESD+ reduced time of procedure compared to ESD (24.5 vs. 32.5 min,
p
= 0.025*). Particularly, ESD+ was significantly faster in retrograde lesions with a median of 22.5 vs. 34.0 min in 3 cm retrograde lesions (
p
= 0.002*) and 34.5 vs. 41.0 min (
p
= 0.011*) in 4 cm retrograde lesions. There were 0 perforations with both techniques. In ESD+ , 1 muscularis damage occurred (3.13%) compared to 6 muscularis damages with ESD (18.75%,
p
= 0.045*).
Conclusions
By its grasp-and-mobilize technique, ESD+ allows potentially faster and safer resections of flat gastric lesions compared to conventional ESD in an ex vivo porcine model. The potential advantages of ESD+ in terms of procedure time may be particularly relevant for difficult lesions in retrograde positions.
Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up ...(PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H - mean 93.0% 95%CI 90.2-95.4, AL-mean 89.7% 95%CI 85.9-92.9 and CL-mean 83.8% 95%CI 76.9-89.7. Pooled durable clinical success proportions were: H-mean 87.5% 95%CI 80.5-93.2, AL-mean 81.4% 95%CI 77.0-85.3 and CL-mean 63.0% 95%CI 53.0-72.3. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.
Purpose
To assess the diagnostic potential of real-time MRI for assessment of hiatal hernias in patients with GERD-like symptoms compared to endoscopy.
Material and methods
One hundred eight patients ...with GERD-like symptoms were included in this observational cohort study between 2015 and 2017. Real-time MRI was performed at 3.0 Tesla with temporal resolution of 40 ms, dynamically visualizing the esophageal transport of a pineapple juice bolus, its passage through the gastroesophageal junction, and functional responses during Valsalva maneuver. Hernia detection on MRI and endoscopy was calculated using contingency tables with diagnosis of hernia on either modality as reference.
Results
Of 108 patients, 107 underwent successful MRI without adverse events; 1 examination was aborted to inability to swallow pineapple juice in supine position. No perforation or acute bleeding occurred during endoscopy. Median examination time was 15 min. Eighty-five patients (79.4%) were diagnosed with hiatal hernia on either real-time MRI or endoscopy. Forty-six hernias were visible on both modalities. Seventeen hernias were evident exclusively on MRI, and 22 exclusively on endoscopy. Sixteen of the 63 MRI-detected hernias (25.4%) were detectable only during Valsalva maneuver, which were smaller compared to hernias at rest (median − 13.5 vs − 33.0 mm,
p
< 0.001). Diagnostic accuracy for hernia detection was comparable for MRI and endoscopy (sensitivity 74% vs 80%,
p
= 0.4223; specificity 100% vs 100%,
p
> 0.99).
Conclusion
Real-time MRI is a fast and safe modality for assessment of the gastroesophageal junction, without radiation exposure or administration of gadolinium-based contrast media. Although MRI and endoscopy yield comparable diagnostic accuracy, dynamic MRI sequences are able to visualize hiatal hernias that were occult on static MRI sequences or endoscopy in a relevant number of cases.
Key Points
• Real-time MRI is a safe and fast imaging modality for examination of the gastroesophageal junction
,
combining anatomical and functional information for enhanced detection of hiatal hernias
.
• Real-time MRI and endoscopy yield comparably high diagnostic accuracy: real-time MRI visualizes hiatal hernias that were occult on endoscopy in a relevant number of patients
;
however
,
several hiatal hernias detected on endoscopy were occult on real-time MRI
.
• There is clinical potential of real-time MR imaging in patients with GERD-like symptoms and equivocal findings on endoscopy or pH-metry
,
for anatomical visualization in patients planned for surgical intervention
,
or those with suspected fundoplication failures
.
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