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Polyps occur significantly less frequently in the upper gastrointestinal tract compared to the lower gastrointestinal tract. They are usually incidental findings at esophagogastroduodenoscopy. A distinction is made between epithelial lesions and subepithelial tumors. Endoscopic screening is not recommended in Germany (exception: hereditary risk groups). Polyps are sometimes symptomatic, generally in the case of advanced tumor size. In this case, or in the case of potential for malignant transformation, resection is necessary and can usually be performed endoscopically. Surgical resections are rarely necessary. Epithelial lesions are removed by means of endoscopic mucosal resection (EMR). For subepithelial tumors, advanced procedures such as endoscopic submucosal dissection (ESD), submucosal tunneling endoscopic resection (STER), or endoscopic full-thickness resection are available. These procedures should primarily be performed at centers with appropriate expertise. Endoscopic follow-up is primarily determined by the tumor entity and the resection status.

Introduction Risk stratification in upper gastrointestinal bleeding (UGIB) currently relies on clinical parameters and risk scores. HemoPill® acute (Ovesco Endoscopy, Tuebingen, Germany) is a pill-shaped, orally administered sensor capsule for real-time blood detection. The aim of this study was to evaluate the system in clinical routine. Material and methods Sixty-one consecutive patients in whom the HemoPill® had been used at 12 international hospitals between July 2019 and March 2020 were retrospectively analysed. Indications for application were the clinical suspicion of UGIB, small bowel bleeding, of rebleeding after hemostasis. Primary endpoints were technical success and bleeding detection/exclusion. Secondary endpoints included adverse events and change of clinical course. Results The capsule was used in 45 (73%) patients with UGIB, in 12 (20%) patients with small bowel bleeding and in four (7%) patients for exclusion of rebleeding. Technical success was 98%. 35/60 (58%) cases were capsule-positive and among these, endoscopy showed bleeding in 20/35 (57%) cases. None of the 25 capsule-negative patients rebled. Emergency endoscopy could be avoided in 18/25 (72%) cases. Serious adverse events did not occur. Conclusion HemoPill®-based blood detection is feasible and safe. Negative capsule results might 'downgrade' the need for urgent endoscopy.

Eine 46-jahrige Patientin stellte sich mit akuten rechtsseitigen Oberbauchschmerzen vor. In der Osophagogastroduodenoskopie wurde eine Duodenalstenose im Bereich der Pars horizontalis duodeni festgestellt. Die Computertomographie des Abdomens, Endosonographie, Doppler‑/Duplexsonographie und Angiographie ergaben in der Zusammenschau ein Aneurysma eines Asts der A. pancreaticoduodenalis inferior innerhalb eines Umgehungskreislaufs von der A. mesenterica superior zur A. hepatica propria. Die Umgehung hatte sich aufgrund eines Verschlusses des Truncus coeliacus gebildet. Die symptomatische Duodenalstenose wurde durch ein lokales Hamatom nach stattgehabter Aneurysmaruptur verursacht. Nach erfolgreichem Coiling des zufuhrenden Gefases zum Aneurysma war das Hamatom in Verlaufskontrollen regredient und die Patientin beschwerdefrei.

Background: This study was designed to compare cisplatin/docetaxel with oxaliplatin/docetaxel in patients with advanced and metastatic non-small lung cancer as a first-line treatment. Methods: Patients were randomly assigned to receive either cisplatin 75 mg m−2 and docetaxel 75 mg m−2 every 3 weeks or oxaliplatin 85 mg m−2 and docetaxel 50 mg m−2 every 2 weeks. The primary end point was response rate, and secondary end points were toxicity, time to progression and overall survival. Results: A total of 88 patients (median age: 65 (39–86) years; stage IV: 93%) were randomly assigned. Response rate (complete and partial response) was 47% (95% CI: 33–61%) in the cisplatin/docetaxel arm and 28% (95% CI: 17–43%) in the oxaliplatin/docetaxel arm (P=0.118). There was no significant difference in time to progression (6.3 vs 4.9 months, P=0.111) and median overall survival (11.6 vs 7.0 months, P=0.102) with cisplatin/docetaxel vs oxaliplatin/docetaxel, although slight trends favouring cisplatin were seen. Oxaliplatin/docetaxel was associated with significantly less (any grade) renal toxicity (56% vs 11%), any grade fatigue (81% vs 59%), complete alopecia (76% vs 27%), any grade leukopenia (84% vs 61%) and grade 3/4 leukopenia (44% vs 14%) and neutropenia (56% vs 27%). Conclusion: Oxaliplatin/docetaxel has activity in metastatic non-small cell lung cancer, but it seems to be inferior to cisplatin/docetaxel.

Aufgrund der speziellen Tumoreigenschaften und der steigenden Inzidenz in den westlichen Landern gibt es zukunftig in der Diagnostik und Therapie von Cholangiokarzinomen noch viele Herausforderungen. Jungste Fortschritte in der Bildgebung und den endoskopischen Techniken zeigen vielversprechende Erfolge. Hauptansatz der aktuellen Forschung und der laufenden Studien ist die Verbesserung auf folgenden Feldern: Tumorfruhdiagnostik, histologische Sicherung, Resektabilitatsprufung und adaquate Angebote zur Lebensverlangerung in der Palliativsituation. Dieser Artikel gibt einen kritischen Uberblick der fur die Cholangiokarzinome aktuell zur Verfugung stehenden diagnostischen und therapeutischen Mittel.

BACKGROUND AND AIM Natural-orifice transluminal endoscopic surgery (NOTES) is an emerging transluminal technique in which interventions are carried out by entering the abdominal cavity via a natural orifice such as the stomach. Infection is a potential risk of the procedure, and the potential pathogens are different from those encountered with skin incisions. Currently, available data regarding prophylactic anti-infective treatment are limited. We compared the effectiveness of topical antimicrobial lavage of mouth and stomach and proton pump inhibitor therapy with gastric cleansing with sterile saline solution in preventing NOTES-related contamination and infection. METHODS A randomized survival swine study was performed. Eight pigs underwent preparation with intravenously administered proton pump inhibitors, mouth and gastric lavage (chlorhexidine), and gastric irrigation (diluted neomycin), plus single-shot intravenous antibiotics. Control group (n = 8) underwent gastric cleansing with sterile saline solution. Peritoneal biopsy, multiple smears, and dilutions for cultures were taken and incubated. The swine were sacrificed after 14 days. Bacterial load was expressed in colony-forming units (CFU). RESULTS One pig died due to gallbladder perforation after 3 days, 2/15 swine presented minor clinical signs of infection in the 14-day follow-up (all 3 pigs were in the control group). Mean C-reactive protein levels were 5.7 +/- 2.4 g/dL (therapy group) and 12.2 +/- 3.8 g/dL (control) ( P = 0.17). Bacterial growth was seen in 1/8 swine (therapy group) and 6/8 swine (control group) ( P = 0.002). Bacterial load was 282 CFU/mL (therapy) vs. 3.2 x 10 (5) CFU/mL (control) ( P = 0.023) in the follow-up. CONCLUSION The use of intravenous antibiotics in addition to topical antimicrobial lavage of mouth and stomach and treatment with proton pump inhibitors decreased the peritoneal bacterial load to almost zero and this was associated with a significantly lower peritoneal infection rate compared with saline-only lavage.

BACKGROUND AND STUDY AIM: Endoscopic mucosal resection (EMR) is a minimally invasive method for en bloc removal of superficial gastrointestinal lesions. The aim of this study was to evaluate the feasibility of a novel grasp-and-snare EMR technique. METHODS: In 10 domestic pigs, gastric lesions of approximately 3 cm were marked using electrocautery. EMR was performed using a double-channel endoscope. A novel tissue anchor was used through one channel, and a monofilament snare through the other. After submucosal injection, a circumferential mucosal incision was created. The tissue-anchoring device was then advanced through the open snare and anchored into the submucosal layer. The tissue-anchoring device was partly retracted into the endoscope and the snare was positioned into the circular incision. The snare was subsequently closed and the specimen resected by applying high-frequency electrocautery. RESULTS: Mean time to perform EMR was 32.4 minutes (range 22 - 41 minutes, SD 6.3). EMR yielded specimens that ranged in area from 2.7 cm (minor axis) by 2.8 cm (major axis) to 4.0 cm by 4.2 cm (mean area 9.36 cm 2 ; range 5.94 - 13.19 cm 2 ; SD ± 2.50). Complete en bloc resection including all electrocautery markings was achieved in 9/10 cases. In one case, resection was achieved in two steps. One gastric wall perforation occurred. No other adverse events were observed. CONCLUSIONS: Grasp-and-snare EMR is feasible in an animal model. The technique can be performed efficiently compared with standard methods. To avoid perforation, caution is needed to ensure that tissue anchor needles are placed within and not deeper than the submucosal layer prior to tissue retraction.

Die Therapie von nicht-varikosen und varikosenoberen gastrointestinalen Blutungen unterscheidet sich grundlegend.Blutungen aus gastroduodenalen Ulcera sind die haufigsteUrsache fur obere gastrointestinale Blutungen. Die Notfalltherapiebesteht aus der Gabe von intravenosen Protonenpumpeninhibitorenund der endoskopischen Blutstillung. Zusatzlich ist dieH. p.-Eradikation und ggf das Absetzen von NSAR von essentiellerBedeutung. Bei Varizenblutung ist die Gabe von vasoaktiven Substanzen unddie fruhe Antibiotikaprophylaxe essentiell. Zur endoskopsichenBlutstillung werden Gummibandligatur und Injektionsverfahren eingesetzt.Die TIPS-Anlage ist bei endoskopisch nicht beherrschbarer Blutungoder fruher Rezidiv-Blutung Therapie der Wahl. The management of upper non-variceal and variceal hemorrhagediffers substantially. Most common cause auf upper gastrointestinal(GI) hemorrhage are gastroduodenal ulcers. Administration of protonpump inhibitors (PPI) and endoscopic hemostasis are crucial in thetreatment of non-variceal bleeding. In case of Helicobacter pyloriinfection eradication therapy should be undertaken and nonsteroidanti-inflammatory drugs (NSAID) discontinued. Early administrationof vasoactive drugs and antibiotics significantly reduces mortalityfrom variceal hemorrhage. Endoscopic hemostasis is achieved withrubber-band ligation or injection therapy. Placement of transjugularintrahepatic portosystemic shunt (TIPS) is indicated in patientswith uncontrolled hemorrhage or recurrent bleeding despite combinedpharmacological and endoscopic therapy.

BACKGROUND AND STUDY AIMS: Perforation of the colon is considered to be one of the most serious complications of flexible endoscopy. The over-the-scope clip system (OTSC) has previously been shown to close small colonic perforations effectively. The aim of this randomized controlled porcine study was to compare acute closure strengths between the novel 11-mm over-the-scope-clip and surgical closure for large colonic perforations. MATERIAL AND METHODS: In 24 anesthetized domestic pigs, an 18-mm sigmoid perforation was created endoscopically using a needle knife and dilating balloon. The animals were randomly assigned to undergo either open surgical repair (n = 12) or endoscopic closure using the OTSC system (n = 12). Pressurized leak tests were performed during necropsy. RESULTS: Mean time to perform the incision in the sigmoid colon and obtain peritoneal access was 5.5 minutes (range 3 - 12; SD ± 2.5). Mean time for endoscopic closure was 6.8 minutes (range 3 - 14; SD ± 3). At necropsy, all OTSC and surgical closures demonstrated complete sealing of colotomy sites. In one case peritoneum and in a second case adjacent small intestine were found incorporated into the OTSC closure. No other complications occurred. Pressurized leak tests revealed a mean burst pressure of 62.8 mmHg (range 18 - 112; SD 35.7) for OTSC closures and 67.4 mmHg (range 30 - 90; SD 19) for sutured closure. No significant differences in burst pressures were noted between the OTSC closures and surgical repair. CONCLUSION: Closure of acute perforations using the OTSC system is comparable to surgical closure in a nonsurvival porcine model.

Wir berichten uber einen 42-jahrigen Patienten mit einem Nebennierenrindenkarzinom, der aufgrund eines bilateralen Visusverlusts und einer hypertensiven Entgleisung aufgenommen wurde. Zusatzlich bestand eine hamolytische Anamie, eine Thrombozytopenie und eine Erhohung der Retentionswerte. Demzufolge wurde die Diagnose einer Gemcitabin-assoziierten thrombotischen Mikrangiopathie gestellt. Unter Therapie mit Prednisolon und antihypertensiver Medikation stabilisierte sich der Patient und erlangte die volle Sehkraft zuruck. Eine Plasmapherese wurde nicht notwendig. Die thrombotische Mikroangiopathie sollte als seltene Komplikation einer Gemcitabintherapie stets bedacht werden.

Heartburn, the most common symptom associated with GERD, occurs in 10-20 % of the US and western European population. Life long PPI therapy for GERD is often required since symptoms typically recur once therapy has been discontinued. Recently a couple of endoscopic antireflux procedures have been developed. These techniques include injection or implantation of biopolymers and application of radiofrequency. Most of the techniques have been abandoned due to lack of long-term efficacy or serious side effects. Since first generation endoluminal suturing techniques showed insufficient durability, due to suture loss, the transmural plication technique Plicator™ was developed. In a prospective-randomized, sham-controlled trial the Plicator proved superiority concerning reflux symptoms, medication use and esophageal acid exposure. Further technical improvements like the use of 2 sutures are currently investigated.

Pericardial and cardiac fistulae secondary to oesophageal or gastric tumours are a rare complication. We report about a 50-year-old male patient with a 10-month history of distal oesophageal carcinoma with lung and liver metastases who was referred to our hospital after 6 cycles of palliative chemotherapy at the beginning of March 2004. The patient presented with dysphagia, dyspnea, tachycardia, and hypotension. Purulent pericardial and bilateral pleural effusion was diagnosed, and the patient was treated with antibiotics, repeated pleurocentesis and pericardial drainage with daily polihexanide lavage. Oesophagogastroduodenoscopy, Peritrast swallow and computed tomographic scans of chest revealed a malignant oesophago-pleuro-pericardial fistula. A total of three coated, expandable metal stents were inserted into the oesophagus, which sealed successfully the fistula. Unfortunately, the patient succumbed to his carcinoma three months later.

History and clinical findings A 68-year-old male was admitted to the hospital with progressive dyspnea and thoracic pain radiating to the shoulder, back and upper abdomen. The patients medical history included hypertension, diabetes and chronic pancreatitis with splenic vein thrombosis. Investigations Laboratory findings showed no signs of myocardial infarction, but pronounced inflammation. The ECG was normal. Chest X-ray revealed a massive left-side pleural effusion with partial lung atelectasis. An abdominal CT-scan showed no signs of acute pancreatitis. Puncture of the pleural effusion revealed elevated amylase and lipase. ERCP showed pancreatic duct stenosis, partial necrosis of the pancreatic body and peripancreatic necrosis with a pancreatico-pleural fistula. Treatment and clinical course After ballon-dilatation of the constricted pancreatic duct, a plastic stent and a nasopancreatic drain were inserted into the necrosis and into the fistula. Drainage and antibiotic therapy led to regression of the necrosis within 3 weeks. With external pleural drainage and octreotide therapy almost complete regression of the pleural effusion and closure of the pancreatico-pleural fistula could be achieved within 3 weeks. Conclusion Complications of chronic pancreatitis such as necrosis and fistulas are rare, but important differential diagnoses in patients with chronic pancreatitis and chest pain. A combination of transpapillary or transgastral endoscopic drainage procedures and pleural drainage, sometimes with additional octreotide therapy is the treatment of choice.

In der westlichen Welt leiden 8–10% der Bevolkerung haufig unter Symptomen einer gastroosophagealen Refluxerkrankung. Die Mehrzahl der Betroffenen wird durch eine Langzeittherapie mit Protonenpumpenhemmern beschwerdefrei. Viele Patienten wunschen jedoch eine Alternative zu einer oft lebenslangen Medikation, die selten auch noch mit Nebenwirkungen oder Unvertraglichkeiten verbunden ist. Daruber hinaus belastet die medikamentose Antirefluxtherapie die Ressourcen der westlichen Gesundheitssysteme mit mehreren Milliarden Euro pro Jahr. Die laparoskopische Fundoplikatio ist im Langzeitverlauf ahnlich effektiv und stellt fur selektionierte Patienten zweifelsohne die bisher einzig sinnvolle Therapiealternative dar. Die Operation wird jedoch nur von weniger als 5% der Patienten in Anspruch genommen. Nebenwirkungen wie zumindest temporare Dysphagie, Vollegefuhl und Flatulenz sind haufiger. Vor diesem Hintergrund besteht ein erhebliches Interesse eines grosen Patientenkollektivs an minimal invasiven Verfahren zur Antirefluxtherapie. In den letzten Jahren wurden eine Reihe unterschiedlicher endoluminaler Techniken entwickelt, die nachfolgend beschrieben und einer ersten Wertung unterzogen werden.

We present an 81-year-old male patient who was diagnosed with proximal jejunal gallstone ileus in succession of acute calculous cholecystitis that had been treated conservatively. The diagnosis was made by ultrasonography, endoscopy, and computed tomography of the abdomen. Immediate treatment was performed as open entero-lithotomy. The gall bladder as well as the cysto-duodenic fistula responsible for migration of the biliary concrement remained untouched. Gall-stone ileus is a rare complication of cholecystitis and requires an immediate diagnosis and treatment. Despite adequate therapy mortality rates reach levels up to 20 %.

ML18147 evaluated continued bevacizumab with second-line chemotherapy for patients with metastatic colorectal cancer (mCRC) progressing after the standard first-line bevacizumab-containing therapy.Evaluating outcomes according to tumor Kirsten rat sarcoma virus oncogene (KRAS) status was an exploratory analysis. KRAS data were collected from local laboratories (using their established methods) and/or from a central laboratory (mutation-specific Scorpion amplification-refractory mutation system). No adjustment was made for multiplicity; analyses were not powered to detect statistically significant differences.Of 820 patients, 616 (75%) had unambiguous KRAS data; 316 (51%) had KRAS wild-type tumors and 300 (49%) had mutant KRAS tumors. The median progression-free survival (PFS) was 6.4 months for bevacizumab plus chemotherapy and 4.5 months for chemotherapy [P0.0001; HR = 0.61; 95% confidence interval (CI): 0.49-0.77] for wild-type KRAS and 5.5 and 4.1 months, respectively (P = 0.0027; HR = 0.70; 95% CI: 0.56-0.89) for mutant KRAS. The median overall survival (OS) was 15.4 and 11.1 months, respectively (P = 0.0052; HR = 0.69; 95% CI: 0.53-0.90) for wild-type KRAS and 10.4 versus 10.0 months, respectively (P = 0.4969; HR = 0.92; 95% CI: 0.71-1.18) for mutant KRAS. In both analyses, no treatment interaction by KRAS status was observed (PFS, P = 0.4436; OS, P = 0.1266).Bevacizumab beyond first progression represents an option for patients with mCRC treated with bevacizumab plus standard first-line chemotherapy, independent of KRAS status.

The use of transluminal endoscopic access via the stomach or colon for flexible diagnostic peritoneoscopy has been proposed, although the diagnostic value of the technique has not yet been fully clarified. In this animal trial, the two main natural orifice transluminal endoscopic surgery (NOTES) approaches - transgastric (TG) and transcolonic (TC) - were compared with standard transabdominal access using both rigid (TAR) and flexible instruments (TAF) for diagnostic laparoscopy.A total of 48 peritoneoscopies were performed using two randomly assigned approaches in 24 anesthetized pigs. The ability of the examinations to detect 576 electrocautery markings simulating intraperitoneal metastases, to achieve complete organ visualization, and to simulate organ biopsies was analyzed.Sensitivities for the detection of lesions were 78.5 %, 59.7 %, 48.6 %, and 38.9 % for TAR, TAF, TC, and TG, respectively; standard laparoscopy was superior to all other approaches (P0.01). Among the NOTES approaches, TC was superior for examining the upper abdomen (P = 0.03). Complete organ visualization was better with the transabdominal approach (visual analogue scale TAR 7.15, TAF 6.71) than with the NOTES access routes (TC 5.07, TG 4.35); standard rigid laparoscopy was superior to both NOTES approaches (P0.01). Organ biopsy simulation was possible in 87 %, 85 %, 72 %, and 65 % of cases with TAR, TAF, TC, and TG, respectively. Standard rigid laparoscopy was again superior to both NOTES approaches (TAR vs. TC, P = 0.03; TAR vs. TG, P0.01).In this experimental trial, rigid standard laparoscopy provided better organ visualization, better lesion detection, and better biopsy capability than the transgastric and transcolonic NOTES approaches. In its current form, NOTES appears to be unsuitable for diagnostic laparoscopy.

BACKGROUND AND STUDY AIMS: Endoscopic closure of the transgastric access site is still a critical area of active research and development into natural orifice transluminal surgery (NOTES). To date, no endoscopic technique has utilized resorbable transmural sutures for closure of the NOTES gastrostomy. MATERIAL AND METHODS: Endoscopic gastrostomy closure by means of resorbable sutures was performed in ten female domestic pigs in an animal survival study. Peritoneal cavity access was gained through the anterior gastric wall using the percutaneous endoscopic gastrostomy (PEG) technique and an 18-mm balloon dilator. NOTES exploration of the gallbladder and tubal ligation were performed prior to endoscopic gastrostomy closure. Necropsy was performed 3 weeks post procedure. RESULTS: Mean suturing time was 26 minutes (range 14 - 35 minutes). In total 90 % (9/10) of gastrostomy closures were performed by means of two transmural resorbable sutures. One gastrostomy was closed using a single resorbable suture. One case of gallbladder perforation occurred during peritoneoscopy and the pig was sacrificed due to subsequent peritonitis 2 days after the procedure. All other pigs (9/10) were found to be healthy 3 weeks after the NOTES procedure and were sacrificed as planned per protocol. Of all the 17 sutures that were applied in the remaining nine pigs, 16 (94 %) had been absorbed, releasing the pledgets intraluminally. During laparotomy no signs of injury to adjacent organs were found in any of these nine animals. In 8/10 pigs (80 %) the gastrostomy site did not burst with pressures exceeding 100 mmHg. Two suturing sites did burst at pressures of 57 and 62 mmHg, respectively. CONCLUSIONS: Endoscopic transmural suturing enables rapid and easy placement of leak-proof resorbable sutures and is suitable for closure of the NOTES transgastric access.

Therapeutic options for advanced hepatocellular carcinoma (HCC) are limited. Bendamustine, a bifunctional cytostatic agent with mainly alkylating effect may be an alternative. Methods: Five HCC cell lines were incubated in vitro with five different concentrations of bendamustine. In addition, cell lines Huh-7 and HepG2 were tested in a chimeric mouse model. Results: In vitro treatment with bendamustine resulted in an IC50

Background and study aims Recently, several endoluminal procedures for the treatment of gastroesophageal reflux disease (GERD) have been introduced. Most of these techniques have been abandoned because they lack long-term efficacy or have serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator was shown to be effective at controlling reflux symptoms and esophageal acid exposure. In all previous studies, only a single implant was used. The aim of the present pilot study was to determine the safety and efficacy of two serially placed Plicator implants. Patients and methods Thirty-seven patients requiring maintenance therapy with proton pump inhibitors (PPIs) were enrolled in this single-center pilot study. All patients received two Plicator implants. Exclusion criteria were hiatus hernia larger than 3 cm, grade IV esophagitis, Barrett's esophagus, and esophageal motility disorders. The primary study end point was at least 50 % improvement in the GERD Health-Related Quality of Life (HRQL) score. Secondary end points included GERD medication use, esophageal acid exposure, esophagitis grade, and heartburn/regurgitation scores. Results Thirty-seven patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months after treatment, the proportion of patients achieving at least 50 % improvement in GERD-HRQL score was 68 %. Complete cessation of PPI treatment was achieved in 59 % of patients. In pH studies conducted at 6 months (n = 29), median percentage of time for which pH was below 4 decreased by 36 %, with 28 % of patients experiencing pH normalization. There were no serious adverse events requiring intervention. Conclusions Endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, medication use, and esophageal acid exposure.

SUMMARY. Placement of self-expanding metal stents (SEMS) for palliation of malignant stenoses at the gastroesophageal junction is often associated with stent migration and reflux symptoms. SEMS with an antireflux mechanism have been developed to overcome the latter problem. The aim of this study was to evaluate the safety and efficacy of antireflux Z-stents. Patients with advanced squamous cell or adenocarcinoma of the distal esophagus or cardia suffering from dysphagia received an antireflux Z-stent. Technical success, complications of the procedure, clinical symptoms before and after stent placement, reinterventions and survival were recorded. Follow-up was accomplished by patient interviews and a standardized questionnaire for primary care physicians. Eighteen consecutive patients received an antireflux Z-stent. Seventeen of 18 stents were placed technically successful in a single endoscopic procedure. Mean dysphagia score improved from 2.2 to 0.6. Four patients (22%) had permanent reflux symptoms, an additional nine (50%) were taking proton pump inhibitors on a regular basis. In 10 patients, a re-intervention was necessary mainly due to dislocation of the stent. To ensure adequate nutrition three and two patients received a percutaneous gastrostomy and a jejunostomy, respectively. Median survival from stent insertion was 54 days (range, 3–201). Although placement of an antireflux Z-stent is technically feasible, its application is hampered by frequent stent migration and insufficient prevention of gastroesophageal reflux. Further technical improvements of stents or alternative methods like brachytherapy are required for satisfactory palliation of malignant gastroesophageal stenosis.

Understanding the physiology of gastric acid secretion and the pathophysiology of acid-related diseases (e.g. gastrooesophageal reflux and peptic ulcer) has led to the development of numerous ways to decrease acid exposure. Pharmacologically one can try to neutralize secreted acid by antacids, prevent stimulation of the parietal cell, improve mucosal defences and block the functioning of the proton pump. Proton pump inhibitors (PPIs) inhibit the final step of acid secretion, and are currently the most potent acid inhibitors. Major therapeutic improvement within the PPI class appears unlikely, as agents in this class share similar chemistry, mode of action, and pharmacokinetic profiles. New approaches that block acid secretion are now being developed. Gastrin (CCK2) receptor antagonists and potassium-competitive acid blockers (P-CABs) are in clinical development.

Biliary tract cancers are rare tumors that have a poor prognosis. Predisposing conditions are characterized by chronic inflammatory and proliferative stimuli of the biliary epithelium. Despite a wealth of diagnostic tools, these cancers are often detected late due to their insidious symptomatic appearance. In patients with localized cancer, surgery is the only curative treatment option. In hilar bile duct tumors, an extended operation including partial hepatectomy may improve long-term outcome. Currently, there is no adjuvant or palliative radio- or chemotherapy available that has been shown to be effective. Treatment in patients with severe comorbidities or advanced stages of disease is directed towards palliation of symptoms. Endoscopic interventions like biliary decompression play a central role in palliative concepts. Prognosis is determined by disease stage and effective prevention of complications, prominent among them being cholangitis.

Benign tumors of the bile ducts are a rarity, while tumors of the gallbladder are more frequently encountered. Benign lesions of the gallbladder are usually detected incidentally, whereas in the bile ducts they may cause obstructive jaundice. The latter should be resected whenever possible, due to the difficulty of differentiating benign lesions from early cancer.

Aim: The PETACC-6 trial investigates the role of oxaliplatin in addition to preoperative chemoradiation (CRT) and adjuvant chemotherapy (CT) with capecitabine to improve disease-free survival (DFS) in locally advanced rectal cancer. Methods: Patients with rectal adenocarcinoma within 12 cm from the anal verge, T3/4 and/or node-positive, without evidence of metastatic disease, considered either resectable at the time of entry or expected to become resectable, were randomized to 5 weeks of preoperative CRT with capecitabine, followed by surgery and 6 cycles of adjuvant CT with capecitabine (standard control arm 1) or capecitabine + oxaliplatin before and after surgery (arm 2). 440 DFS events were required to have 80% power to detect an improvement in 3-year DFS from 65% to 72% (HR = 0.763), with two-sided alpha of 5% and allowing for an interim analysis for early efficacy at 200 events. Results: 1094 patients were randomized (547 in each arm). From 1081 eligible patients, 543 in arm 1 and 528 in arm 2 started preoperative treatment (3/528 patients without oxaliplatin in arm 2), and of these 77.3% and 72.6%) patients started postoperative chemotherapy within protocol. In arm 2, 11.8% patients did not receive the planned postoperative oxaliplatin. Major reasons for protocol discontinuation were progressive disease (3.9% in arm 1 vs. 3.8% in arm 2), toxicity (7.7% vs. 16.5%), surgery complication (8.7% vs. 9.1%), patient's refusal (5.9% vs. 10.8%). At planned interim analysis, the independent data monitoring committee recommended the early release of the results. At a median follow-up of 31months, 124 and 121 DFS events were observed in arm 1 and 2 (adjusted HR = 1.036, 95% CI: 0.81 -1.33, P = 0.78). 3-year DFS was 74.5% (95% CI: 70.1% - 78.3%) in arm 1 (which is higher than anticipated) vs. 73.9% (95% CI: 69.5% - 77.8%) in arm 2; conditional power under HR = 0.763 is only 7%. Less locoregional and distant failures were recorded in the experimental arm with oxaliplatin (95 in arm 2 vs. 109 in arm 1) but a higher rate of deaths without progression (26 in arm 2 vs. 15 in arm 1). Conclusions: Interim results at a median follow up of 2.6 y currently indicate no DFS-benefit for the addition of oxaliplatin to capecitabine-based CRT and adjuvant CT. However, with actually only 245 out of the required 440 events, final evaluation cannot be done before at least 2 further years follow-up. Disclosure: H.J. Schmoll: has a consultant or advisory relationship to disclose with Roche, Sanofi and Bayer; has honoraria to disclose from Roche; has research funding to disclose from Merck and Roche; K. Haustermans: has research funding to disclose from Roche; T.J. Price: has a consultant or advisory relationship to disclose with Roche; R. Hofheinz: has a consultant or advisory relationship to disclose with Roche; has honoraria and research funding to disclose from Roche; B. Brenner: has a consultant or advisory relationship to disclose with Sanofi-Aventis; has research funding to disclose from Sanofi-Aventis; J. Zalcberg: has a consultant or advisory relationship to disclose with Sanofi-Aventis and Roche; has honoraria, research funding and other remuneration to disclose from Sanofi-Aventis and Roche. M.P. Lutz: has a consultant or advisory relationship to disclose with Roche; E. Van Cutsem: has research funding to disclose from Roche and Sanofi.All other authors have declared no conflicts of interest.

3501 Background: The PETACC-6 trial investigates whether the addition of oxaliplatin to preoperative oral fluoropyrimidine-based chemoradiation (CRT) followed by postoperative adjuvant fluoropyrimidine-based chemotherapy (CT) improves disease-free survival (DFS) in locally advanced rectal cancer. Methods: Between 11/2008 and 09/2011, patients with rectal adenocarcinoma within 12 cm from the anal verge, T3/4 and/or node-positive, with no evidence of metastatic disease and considered either resectable at the time of entry or expected to become resectable, were randomly assigned to receive 5 weeks of preoperative CRT with capecitabine, followed by 6 cycles of adjuvant CT with capecitabine with (arm 2) or without (arm 1) the addition of oxaliplatin before and after surgery. 440 DFS events were required to have 80% power to detect an improvement in 3-year DFS from 65% with capecitabine alone to 72% with capecitabine and oxaliplatin (HR=0.763) using a two-sided alpha of 5% and owing for an interim analysis for ...