Hemospray application in nonvariceal upper gastrointestinal bleeding: results of the Survey to Evaluate the Application of Hemospray in the Luminal Tract.

BACKGROUND: Hemospray TM (TC-325) is a novel hemostatic agent licensed for use in nonvariceal upper gastrointestinal bleeding (NVUGIB) in Europe. GOALS: We present the operating characteristics and performance of TC-325 in the largest registry to date of patients presenting with NVUGIB in everyday clinical practice. METHODS: Prospective anonymized data of device performance and clinical outcomes were collected from 10 European centers using the multicentre SEAL survey (Survey to Evaluate the Application of Hemospray in the Luminal tract). TC-325 was used as a monotherapy or as second-line therapy in combination with other hemostatic modalities at the endoscopists' discretion. RESULTS: Sixty-three patients (44 men, 19 women), median age 69 (range, 21 to 98) years with NVUGIB requiring endoscopic hemostasis were treated with TC-325. There were 30 patients with bleeding ulcers and 33 with other NVUGIB pathology. Fifty-five (87%) were treated with TC-325 as monotherapy; 47 [85%; 95% confidence interval (CI), 76%-94%] of them achieved primary hemostasis, and rebleeding rate at 7 days was 15% (95% CI, 5%-25%). Primary hemostasis rate for TC-325 in patients with ulcer bleeds was 76% (95% CI, 59%-93%). Eight patients, who otherwise may have required either surgery or interventional radiology, were treated with TC-325 as second-line therapy after failure of other endoscopic treatments, all of whom achieved hemostasis following the adjunct of TC-325. CONCLUSIONS: This multicentre registry identifies potentially useful characteristics of Hemospray (TC-325) when used either as monotherapy or as a rescue therapy in a wide variety of ulcer and nonulcer NVUGIB.

Impact of aspirin, NSAIDs, warfarin, corticosteroids and SSRIs on the site and outcome of non-variceal upper and lower gastrointestinal bleeding.

OBJECTIVE: To assess the impact of increased use of low-dose aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, corticosteroids and selective serotonin re-uptake inhibitors (SSRIs) on the site and outcome of non-variceal gastrointestinal (GI) bleeds. METHODS: Retrospective review of 731 patients with peptic ulcer bleeds (PUBs), non-ulcer, non-variceal upper (NUUPGIBs) and lower GI bleeds (LGIBs) in 1984, 1994 and 2004 at Lund University Hospital, Sweden. Incidence and mortality rates, risk factors for fatal outcome and associations with different sites of GI bleeds were evaluated. RESULTS: Between 1984 and 2004, incidence of PUBs decreased from 62.0 to 32.1 per 100,000 inhabitants (p<0.001). Incidence of NUUPGIBs (29.0-30.4 per 100,000) and LGIBs (45.5-43.2 per 100,000) was stable. The case-fatality rate ranged from 4-6% (p=0.65) for upper GI bleed to 1-8% (p=0.033) for LGIB. No drug impacted on fatal outcome. Aspirin, warfarin and SSRI users tended to suffer more severe GI bleeds than non-users of these drugs. When comparing non-ulcer GI bleeds with PUBs, aspirin (OR 0.56, 95% CI 0.38-0.82) was more strongly associated with PUBs, whereas SSRIs (OR 3.71, 95% CI 1.39-12.9) and corticosteroids (OR 2.8, 95% CI 1.28-6.82) were more associated with non-ulcer GI bleeds after adjusting for age, gender and co-morbidity. CONCLUSION: Increased use of drugs that promote bleeding has not impacted on incidence and fatal outcome of non-variceal GI bleeds, although the severity of bleeding has increased. Aspirin is more strongly associated with PUBs, while corticosteroids and SSRIs are associated with non-ulcer, non-variceal GI bleeds.

Impact of proton pump inhibitors on benign anastomotic stricture formations after esophagectomy and gastric tube reconstruction: results from a randomized clinical trial.

OBJECTIVE: The primary aim of this study was to evaluate if the use of proton pump inhibitors (PPIs) reduced the prevalence of benign anastomotic strictures after uncomplicated esophagectomies with gastric tube reconstruction and circular stapled anastomoses. SUMMARY BACKGROUND DATA: Benign anastomotic strictures are associated with anastomotic leaks or conduit ischemia. Also patients without those complications develop benign anastomotic strictures. We hypothesize that patients without postoperative anastomotic complications may develop benign anastomotic strictures due to exposure of acid gastric tube contents to the anastomotic area, and that the formation of such strictures may be reduced by prophylactic use of PPIs. METHODS: Eighty patients without preoperative chemo- or radiotherapy, without clinical or radiological signs of anastomotic leaks were included in this clinical trial. The patients were randomized to b.i.d. PPIs or no treatment for 1 year. Benign anastomotic strictures were defined as anastomotic narrowing not allowing a standard diagnostic endoscope to pass without dilatation. The study was registered in the EudraCT database (2009-009997-28) for clinical trials. RESULTS: : Seventy-nine patients were evaluated. Benign anastomotic strictures developed in 5/39 (13%) patients in the PPI group and in 18/40 (45%) in the control group (RR 5.6, 95% CI: 2.0-15.9, P = 0.001). The use of a narrower 25 mm cartridge as compared to a wider 28 or 31 mm cartridge significantly increased stricture formations (RR 2.9, 95% CI: 1.1-7.6, P = 0.025). CONCLUSIONS: Prophylactic PPI treatment reduced the prevalence of benign anastomotic strictures following esophagectomy with gastric tube reconstruction and circular stapled anastomoses. Larger sized circular staple cartridges additionally reduced the stricture prevalence.

Sharp recanalization of the esophageal occlusion using transjugular access set. Report of two cases.

Two male patients, 75 and 53 years old, with totally occluded esophagus were treated. Sharp recanalization was performed using a combined radiologic and endoscopic technique. Following successful penetration with the needle through the occluded segment and balloon dilation, the created channel was stabilized with esophageal stent, with subsequent palliative effect.

Two different surgical approaches in the treatment of adenocarcinoma at the gastroesophageal junction.

BACKGROUND: Adenocarcinoma at the gastroesophageal junction may be regarded as of esophageal or of gastric origin, and tumor removal may follow the principles of esophagectomy or extended gastrectomy. We determined the impact of this strategy on our patients with tumors at this site. METHODS: Baseline patient and tumor characteristics were collected, and tumors were categorized according to Siewert's classification (I, II, or III) of gastroesophageal junction tumors. Totally, 133 patients were operated on between 1990 and 2001. Ninety-six patients with type I (n = 67), II (n = 26), and III (n = 3) tumors underwent esophagectomy and gastric tube reconstruction, and 37 patients with type I (n = 5), II (n = 26), and III (n = 6) tumors underwent extended gastrectomy and long Roux-en-Y reconstructions. RESULTS: After adjusting for the independently significant impact factors-tumor stage, tumor dissection (R0-R2), and length of tumor free resection margins-we did not find any specific survival benefit associated with either of the two evaluated surgical approaches for tumor resection and reconstruction. The EORTC quality of life forms revealed good results as indicated by the functional scales and the symptom scales. CONCLUSIONS: Provided that adequate tumor dissection is performed, patients with adenocarcinoma at the gastroesophageal junction can be resected and reconstructed using the principles for esophagectomy or extended gastrectomy.

Cervical or thoracic anastomosis after esophageal resection and gastric tube reconstruction: a prospective randomized trial comparing sutured neck anastomosis with stapled intrathoracic anastomosis.

OBJECTIVE: The purpose of the study was to compare in prospective randomized fashion a manually sutured esophagogastric anastomosis in the neck and a stapled in the chest after esophageal resection and gastric tube reconstruction. SUMMARY BACKGROUND DATA: Despite the fact that all reconstructions after esophagectomy will result in a cervical or a thoracic anastomosis, controversy still exists as to the optimal site for the anastomosis. In uncontrolled studies, both neck and chest anastomoses have been advocated. The only reported randomized study is difficult to evaluate because of varying routes of the substitute and different anastomotic techniques within the groups. The reported high failure rate of stapled anastomoses in the neck and the fact that most surgeons prefer to suture cervical anastomoses made us choose this technique for anastomosis in the neck. Our routine and the preference of most surgeons to staple high thoracic anastomoses became decisive for type of thoracic anastomoses. METHODS: Between May 9, 1990 and February 5, 1996, 83 patients undergoing esophageal resection were prospectively randomized to receive an esophagogastric anastomosis in the neck (41 patients) or an esophagogastric anastomosis in the chest (42 patients). To evaluate selection bias, patients undergoing esophageal resection during the same period but not randomized (n = 29) were also followed and compared with those in the study (n = 83). Objective measurements of anastomotic level and diameter were assessed with an endoscope and balloon catheter 3, 6, and 12 months after surgery. The long-term survival rates were compared with the log-rank test. RESULTS: Two patients (1.8%) died in hospital, and the remaining 110 patients were followed until death or for a minimum of 60 months. The genuine 5-year survival rate was 29% for chest anastomoses and 30% for neck anastomoses. The overall leakage rate was 1.8% (2 cases of 112) with no relation to mortality or anastomotic method. All patients in the randomized group had tumor-free proximal and distal resection lines, but 1 patient in the nonrandomized group had tumor infiltrates in the proximal resection margin. At 3, 6, and 12 months after operation, there was no difference in anastomotic diameter between the esophagogastric anastomosis in the neck and in the thorax (P = 0.771), and both increased with time (P = 0.004, ANOVA repeated measures). Body weight development was the same in the two groups. With similar results in randomized and nonrandomized patients, study bias was eliminated. CONCLUSIONS: When performed in a standardized way, neck and chest anastomoses after esophageal resection are equally safe. The additional esophageal resection of 5 cm in the neck group did not increase tumor removal and survival; on the other hand, it did not adversely influence morbidity, anastomotic diameter, or eating as reflected by body weight development.