Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study.

INTRODUCTION: The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB. PATIENTS AND METHODS: In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4-7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test. RESULTS: Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001). CONCLUSIONS: This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.

[Full thickness resection device (FTRD). Experience and outcome for benign neoplasms of the rectum and colon]. / Full-Thickness-Resection-Device (FTRD). Die endoskopische Vollwandresektion für das Rektum und Kolon.

BACKGROUND: The diagnostic validity of a full-thickness resection is higher compared to endoscopic mucosal resection (EMR) or endoscopic mucosal dissection (ESD). Whereas transanal endoscopic microsurgery techniques (TEM, TAMIS) are established therapeutic procedures in the rectum no established and safe minimally invasive or endoscopic procedure exists in the colon. AIM: In this study the novel endoscopic full thickness resection device (FTRD, Ovesco, Germany) was investigated concerning success rates with histologically proven full thickness resections, R0 status as well as patient and device safety for the rectum and colon. METHOD: In the period from November 2014 to June 2015 full thickness resections in the rectum and colon were performed with the FTRD in 20 patients. Data on technical success, R0 resection rate and histologically confirmed full thickness resections were retrospectively analyzed. RESULTS: The following indications were treated in the rectum (n = 11) and colon (n = 9): T1 carcinoma (n = 6) and neuroendocrine tumors (n = 2), untreated and nonlifting adenomas (n = 3) and incomplete resection of adenomas with low and high grade dysplasia (n = 9). The technical success rate was 75 %, 3 technical failures made a conventional polypectomy necessary in 2 patients and in 1 patient an operative resection of the duplicated intestinal wall had to be performed. The median endoscopic follow-up time was 61.5 days (n = 10) and in 7 patients the clip had dislodged at the first follow-up. A thermal perforation in one case of conventional polypectomy gave rise to indications for a partial resection of the colon. In one patient the lesion in the cecum could be reached but not treated for technical reasons. The histological R0 rate was 80 %, whereas the full thickness resection rate was 60 % (85.7 % in the colon and 54.6 % in the rectum). In two patients with carcinoma and incomplete FTRD, surgical treatment was performed. The median size of the resection specimen was 5  cm(2) (range 1.6-12.9  cm(2)). CONCLUSION: The results show that FTRD is a safe and effective instrument for use in the lower gastrointestinal tract. Limitations of the FTRD system concerning full thickness resection are scarring, fibrosis and thickness of the intestinal wall, especially in the lower rectum; therefore, it is suggested that a simulation with a tube similar in size to the FTRD should be performed during the screening colonoscopy in order to establish whether an endoscopic resection with FTRD is possible.

[Buried bumper syndrome: A new classification and therapy algorithm]. / Buried-bumper-Syndrom : Eine neue Klassifikation mit Therapiealgorithmus.

BACKGROUND: Buried bumper syndrome (BBS) is a severe complication of percutaneous endoscopic gastrostomy (PEG) based on the overgrowth of gastric mucosa over the inner bumper of a PEG and migration into the gastric or abdominal wall and with a highly variable incidence ranging between 0.9 and > 8 %. However, no classification has yet been described setting the extent of migration of the inner bumper in relation to therapy and the related risk, especially of perforation. OBJECTIVES: In the past 12 years 38 patients presented with BBS. Initially, an attempt was made to treat all BBS patients endoscopically. A structured BBS classification into four types for estimation of the therapy risk was developed. METHOD: BBS classification: IA: inner bumper partially extrakorporeal or subcutaneous with and without fistula; IB: inner bumper completely extrakorporeal, full thickness focal defect; II: partially visible inner bumper inside the stomach, good degree of mobility; IV: deep type., inner bumper not visible, mucosa without mobility. RESULTS: Up to August 2014, examiners with different degrees of experience classified and treated 17 BBS patients according to the algorithm described above (type IA n = 2, type IB n = 2, type II n = 3, type III n = 4 and type IV n = 6). Problem-free endoscopic therapy was possible in all of the patients in whom good mucosa mobilization with or without partial identification of the inner PEG bumper could be previously induced. CONCLUSION: The classification serves as an aid and takes both the therapist's experience and patient safety into consideration. In estimating the risk, it considers the following prevailing circumstances: More stringent obligation for patient information under the Patient Rights Act, with presentation of possibly necessary expansion of therapy; the obligation to cite relative alternative treatments; prior check of the resources available (specialist/surgery available yes/no).

Video. Laparoscopic extirpation of a fork from the duodenum.

BACKGROUND: A 23-year-old woman who 2 weeks before visiting our institution swallowed a plastic fork while attempting to induce vomiting during a party presented with progressive abdominal pain. Various techniques for removing foreign bodies from the intestinal tract have been described. We present the laparoscopic retrieval of a 15-cm fork from the duodenal bulb. METHODS: The patient presented with leukocytosis and epigastric tenderness. An upper endoscopy revealed a plastic fork, tines up, perforating the duodenal bulb. The handle was irremovably lodged in the opposite part of the duodenum. Perforating objects and objects larger than 7 cm ought to be removed surgically to prevent esophageal perforation. The patient was placed in supine position with the surgeon standing between her legs. Four trocars, two 10-mm and two 5-mm, were used. We saw a slight swelling of the duodenum with few fibrin stripes and roughly 250 ml of white exudate. The fork tines were visible; there were no injuries to the liver. The tines were held with a clamp while the perforated intestinal wall was carefully dissected with a monopolar hug and later with an ACE harmonic scalpel due to bleeding. The fork was extracted in the proximal direction through the perforation injury. There was no severe necrosis and debridement was not necessary. The bowel was irrigated and continuously sutured with 3-0 PDS. Finally, the fork was retrieved through the 10-mm trocar incision. RESULTS: Operating time was 60 min and blood loss was roughly 100 ml. The patient's postoperative course was uneventful. One year after intervention, the patient is doing well. CONCLUSION: A fork may be swallowed, but usually does not spontaneously pass through the gastrointestinal tract. Early removal should be advised to avoid perforation and to minimize morbidity. Laparoscopic removal is a safe and feasible method of managing foreign bodies that are not removable endoscopically.

[Percutaneous endoscopic gastrostomy. Complications with and without anticoagulation]. / Perkutane endoskopische Gastrostomie. Komplikationen mit und ohne Antikoagulation.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) has been classified to date as a high-risk procedure (ASGE guidelines). Coagulopathies, thrombocyte aggregation inhibitors (Aspirin, clopidogrel etc.) and phenprocoumone or warfarin are considered to be contraindications. The study examined for the first time the risk factors in patients with and without concurrent anticoagulation. METHODS: Between 2001 and 2007 PEGs were placed in 450 patients with neurological diseases at the University Hospital for General and Visceral Surgery in Freiburg and studied prospectively during hospitalization. The patients were divided into 3 groups: group 1 controls (n=50, no anticoagulation), group 2 low-molecular-weight heparin (LMWH) prophylaxis (n=152) and group 3 therapeutic anticoagulation (unfractionated heparin, phenprocoumone, therapeutic LMWH, aspirin, clopidorel and combinations, n=248). Univariate analyses were performed to determine risk factors for the occurrence of infection, bleeding and peritonitis. The p-values (p), odds ratios (OR) and 95% confidence intervals (CI) are given. RESULTS: The average hospitalization time was 27.4 days (range 1-268 days) and hospital mortality was 6%. There were no cases of death due to the PEG. Complications included peristomal infections (n=30, 6.6%) and peritonitis (n=6, 1.3%). Post-PEG bleeding did not occur either with or without anticoagulation. The investigated risk factors showed no statistically significant values with respect to prognosis for these complications. Multivariate testing could not be carried out due to the low number of complications. CONCLUSION: Complications of PEG placement with the method used here are rare. An increased risk of bleeding during therapeutic anticoagulation was not observed. In our opinion the present data indicate that PEG placement can be carried out in selected patients with increased risk of thromboembolism without discontinuation of anticoagulation.

Endoscopic bougienage of benign anastomotic strictures in patients after esophageal resection: the effect of the extent of stricture on bougienage results.

SUMMARY: The aim of our retrospective study was to determine the incidence of benign anastomotic strictures (BAS) in patients after esophageal resection and to examine the influence of the extent of BAS on the results of bougienage therapy. From January 2001 to July 2006, 79 patients at risk of BAS development were included in the study. BAS was diagnosed with a median delay of 8 weeks (4-26) postoperative in 23 patients (29%). A median of 4 bougienage sessions (2-20) was needed for success (success rate 100%). The mean follow-up time was 22 months [range 3-47]. There were no late recurrences of BAS. Five patients had an anastomosis diameter <5.5 mm and 14 patients >5.5 mm. There was no difference in median number of bougienage procedures in these subgroups (4.5 [2-9] vs. 4 [2-20]). Patients who presented with BAS earlier than 6 weeks postoperative had more procedures (median 8 [2-20] vs. 4 [2-9]) than those presenting later. Patients in whom first bougienage was possible to only 16 mm diameter needed more procedures than patients in whom first dilation was possible to more than 16 mm (median 5.5 [3-20] vs. 3 [2-9]). In conclusion, both early BAS development and the diameter of bougienage at first endoscopy, but not the extent of stricture, seem to be predictive factors for longer bougienage therapy. In order to influence the BAS formation early, we now routinely examine every patient after esophageal resection endoscopically in the 6th postoperative week.

Transanal endoscopic tube decompression of acute colonic obstruction: experience with 51 cases.

BACKGROUND: Acute colorectal obstruction is a potentially life-threatening emergency that requires immediate surgical treatment. To avoid major postoperative complications, most surgeons advocate two-step surgery despite the increase in patient discomfort and cost. Various methods for performing one-step surgery have been reported including intraoperative colonic lavage, decompression with self-expandable metal stents, and transanal tube decompression. METHODS: The authors present their experience performing transanal colonic decompression for 51 patients. RESULTS: Endoscopic tube placement was successful for 43 (84%) of the 51 patients. The emergency clinical situation could be converted to semielective treatment in 37 cases (73%) (30 operations and 6 nonoperative interventions), and to an elective operation in 1 case. After successful colonic decompression, the rate of one-stage operations was 93% (28/30), as compared with 40% (4/10) if the decompression failed. CONCLUSION: Endoscopic tube decompression of acute colonic obstruction is an easy and cost-effective possibility for avoiding emergency operations with all their sequelae. Emergency surgery can be converted to semielective or elective surgery, markedly reducing the rate of staged operations.

Nonoperative treatment of four esophageal perforations with hemostatic clips.

Spontaneous or iatrogenic esophageal perforations are despite advances of modern surgery and intensive care medicine still potentially life-threatening events with a considerable mortality rate. Recently, encouraging results on the sealing of esophageal perforations by placement of endoluminal prostheses were reported. However, if the perforation is very proximal (close to the larynx) or very distal (involving the cardia), the situation is to our experience unsuitable for stent therapy. In these special cases non-operative treatment is still possible by application of hemostatic metal clips. We present four cases unsuitable for stent therapy where the perforation was sealed by endoscopic clip application. All patients had an uneventful recovery. Non-operative treatment of esophageal perforations with hemostatic metal clips is feasible and safe in cases not treatable with self-expanding metal stents.

[Dynamic graciloplasty vs artificial bowel sphincter in the management of severe fecal incontinence]. / Schliessmuskelprothese vs. Ersatzmuskelplastik bei hochgradiger Stuhlinkontinenz? Eine quantitative Analyse.

Dynamic graciloplasty (DGP) and the Acticon Neosphincter (artificial bowel sphincter, ABS) are well-established therapeutic instruments in patients with severe fecal incontinence. However, the success rates in the literature must be interpreted with caution. The report presented here presents firstly a critical analysis of 1510 patients in 52 studies (29 DGP vs 23 ABS). The evidence of these studies was assessed using the Oxford EBM criteria. All data were statistically analysed. Up to 94% of the studies analysed show EBM levels of only >3b. Both procedures show significant improvements in postoperative continence scores (p<0.001) and a significant advantage of ABS over DGP. Nevertheless, they are associated with a high incidence of morbidity in the long term (infection rate ABS vs DGP 21.74% vs 35.1%, revision rate ABS vs DGP 37.53% vs 40.64%, and ABS explantation rates of 30%). Presently no therapeutic recommendation can be expressed based on the few data available. Furthermore, therapy should be performed in specialized centers and patients should be given a realistic picture of the critical outcome of both surgical techniques.

[German Artificial Sphincter System--GASSII: first in vivo evaluation of a novel and highly integrated sphincter prosthesis for therapy of major fecale incontinence]. / German Artificial Sphincter System-GASS II: Erste in vivo Evaluation eines neuen hochintegrativen Neosphinkters zur Therapie der hochgradigen Stuhlinkontinenz.

The German Artificial Sphincter System GASS consists of a support ring which includes a fluid reservoir on the outer side and an occlusive cuff on the inner side. The cuffs are designed as polyurethane hollow bodies with a pre-determined inflation volume and are connected to an integrated piezo micropump/valve unit. To evaluate the threshold of continence, the GASS was placed around the anorectal junction via a perineal approach in one mini pig. The novel cuff design reduces the occlusion pressure and allows low compression volumes. Low operating pressures indicate a minor risk of ischemia injury of the bowel. The operation time is estimated at about 6 days with no recharging of the battery. The novel remote controlled GASS is a highly integrated prosthesis for placement around the anal canal or lower rectum and is effective in restoring continence for liquids and solids in vitro and in vivo.

Electrodynamic smooth muscle sphincter: development and biomechanical evaluation of a novel porcine artificial smooth muscle sphincter in a new in vitro stoma simulator.

AIM: Many authors have suggested that the activity of the enteric inhibitory nerves is important in regulating normal gastrointestinal motility and inducing smooth muscle relaxation. Hitherto, no experimental or clinical models exist that transfer these physiological aspects to creating an autologous artificial sphincter for the treatment of major incontinence. Therefore, this study was performed to determine the contractile and relaxant capacity of gastrointestinal muscle types and to investigate the efficiency of a novel smooth muscle sphincter, based on the non-adrenergic, non-cholinergic (NANC) receptive relaxation under electrical field stimulation (EFS). METHODS: For the first step, the isometric tension from isolated circular porcine fundus and colon muscle strips was recorded during pharmacological stimulation (TTX, L-NNA and atropine) and EFS. As a result, a continent electrodynamic smooth muscle sphincter (ESMS) was created by wrapping a fundus muscle flap around an isolated segment of porcine distal colon. The EFS of the free nerve fibers of the flap was realized using a circular platinum wire electrode. Parameters such as threshold of continence, intra/preluminal pressure and fluid passage were analyzed in a newly designed in vitro stoma simulator. RESULTS: Electrical field stimulation produced a maximal and voltage-dependent fundus relaxation to --12.4 mN/mm(2) (frequency of 40 Hz, pulse duration, train duration and voltage of 5 ms, 1 s and 60 mA respectively), which were abolished by N-nitro-L -arginine (L-NNA; 10(-4) M) in a dose-dependent manner, confirming that relaxant responses were mediated by NANC nerves. The results of eight ESMS showed that circular electrical stimulation of the muscle flap caused muscle relaxation with a concomitant and effective reduction in the occlusion pressure. CONCLUSION: The NANC-induced relaxation mechanism of porcine fundus preparations could be transferred to an efficient smooth muscle sphincter with a high threshold of continence and electrically controlled defecation.

Clonal T-cell receptor gamma-chain gene rearrangement by PCR-based GeneScan analysis in advanced cutaneous T-cell lymphoma: a critical evaluation.

Detection of clonal T-cell receptor gamma (TCRgamma)-chain gene rearrangement is a promising approach to distinguish between cutaneous T-cell lymphomas (CTCLs) and reactive T-cell infiltrates. Despite the improved sensitivity by using the polymerase chain reaction (PCR) rather than Southern blot analysis, monoclonality could be demonstrated in only 53-90 per cent of CTCL biopsies in recent studies. In the present study, formalin-fixed, paraffin-embedded specimens of 21 selected patients with clear-cut advanced-stage CTCL were analysed using a semi-nested TCRgamma PCR with newly developed consensus primer pairs. Detection of PCR products was done by GeneScan analysis (GSA); this technique is advantageous due to its sensitivity and accuracy in the detection and size determination of PCR products and it is easier to interpret than direct read-outs from TGGE or DGGE gels. In serial dilution experiments, TCRgamma-PCR-GSA allowed the detection of clonal, rearranged T-cells with a high in vitro sensitivity against a polyclonal background (1-6 per cent). Despite the selection of clear-cut, advanced-stage CTCL cases, however, dominant clonal TCRgamma-chain gene rearrangement was found in only 16 of the 21 patients analysed, indicating an overall clinical sensitivity of 76 per cent. Specificity was evaluated using biopsy specimens from 21 control patients suffering from long-standing psoriasis (n=13) and eczema (n=8). Surprisingly, GeneScan profiles showing apparently single dominant peaks were detected in 14 per cent of these skin lesions, but these profiles turned out to be pseudo-monoclonal by repeated determinations. In conclusion, TCRgamma-PCR-GSA does not suffice reliably to exclude malignancy, due to its limited clinical sensitivity, but with precautions taken to detect pseudo-monoclonality and to secure specificity, TCRgamma-PCR-GSA is a valuable instrument in the diagnosis of CTCL.

Experimental study of a novel phospholipase A2 inhibitor in acute pancreatitis.

BACKGROUND: In acute pancreatitis, two different types of secretory phospholipase A2 (PLA2) have been found: pancreatic type I PLA2 and non-pancreatic type II PLA2. In this study a potent new PLA2 inhibitor effective against type II PLA2 was used in an experimental model of acute pancreatitis. METHODS: In 70 rats the efficacy of the compound was analysed in two experimental models of acute pancreatitis: cerulein- and taurocholate-induced acute pancreatitis, imitating mild and severe disease respectively. Serum rat type I PLA2 protein concentration and type I and type II PLA2 catalytic activities were measured while giving the inhibitor therapeutically. In a prophylactic protocol the effect on histology was analysed. RESULTS: In the taurocholate model, type II PLA2 activity was found to be nine-fold higher than in the cerulein model (P < 0.002), whereas the activity of type I PLA2 was not increased. The inhibitor significantly decreased serum type II PLA2 activity in the taurocholate model of acute pancreatitis (P < 0.05) but type I PLA2 protein concentration and type I PLA2 activity were not affected. The inhibitor also reduced histological tissue damage, with significant differences at 3 and 12 h (P < 0.01). CONCLUSION: The PLA2 inhibitor significantly reduced type II PLA2 activity and was able to protect the pancreas against tissue damage. PLA2 inhibition offers the possibility of a treatment for acute pancreatitis.

Pathophysiological role of secretory type I and II phospholipase A2 in acute pancreatitis: an experimental study in rats.

BACKGROUND: In human acute pancreatitis two different types of secretory phospholipase A2 (PLA2) have been found. AIM: To analyse the specific pattern of distribution of these PLA2 activities and their pathophysiological role in experimental acute pancreatitis. SUBJECTS AND METHODS: Catalytic activities of secretory type I (pancreatic) and type II (non-pancreatic) PLA2 and the protein concentration of immunoreactive pancreatic PLA2 (IR-PLA2) in serum and pancreatic tissue of rats with cerulein (mild form) and sodium taurocholate (severe form) induced acute pancreatitis were determined. RESULTS: Cerulein infusion caused a significant increase in type I PLA2 activity (p < 0.01) and IR-PLA2 protein concentration (p < 0.01) in serum and pancreas, whereas type II PLA2 activity remained unchanged during the 12 hour observation period. Histology showed no significant tissue destruction. In sodium taurocholate induced acute pancreatitis type II PLA2 activity significantly increased, reaching values over 10-fold higher than controls (p < 0.01), whereas IR-PLA2 protein concentration and type I PLA2 activity were only marginally increased. In this severe model of acute pancreatitis significantly lower values were detected than in the control pancreas (p < 0.002) for PLA2 activity and IR-PLA2 protein concentration. Histology showed parenchymal and fat necroses with haemorrhage, oedema, and inflammatory cell infiltration. CONCLUSIONS: Type I PLA2 activity is dependent on the IR-PLA2 protein concentration in serum and pancreatic tissue. The type II PLA2 activity is not stimulated by cerulein, which indicates an extra-acinar origin of this enzyme. Type II PLA2 activity is significantly increased in sodium taurocholate induced acute pancreatitis indicating its role in the local necrotising process and involvement in the systemic effects in severe acute pancreatitis.