Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study.

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

Hemostatic powder TC-325 treatment of malignancy-related upper gastrointestinal bleeds: International registry outcomes.

BACKGROUND AND AIM: Upper gastrointestinal tumors account for 5% of upper gastrointestinal bleeds. These patients are challenging to treat due to the diffuse nature of the neoplastic bleeding lesions, high rebleeding rates, and significant transfusion requirements. TC-325 (Cook Medical, North Carolina, USA) is a hemostatic powder for gastrointestinal bleeding. The aim of this study was to examine the outcomes of upper gastrointestinal bleeds secondary to tumors treated with Hemospray therapy. METHODS: Data were prospectively collected on the use of Hemospray from 17 centers. Hemospray was used during emergency endoscopy for upper gastrointestinal bleeds secondary to tumors at the discretion of the endoscopist as a monotherapy, dual therapy with standard hemostatic techniques, or rescue therapy. RESULTS: One hundred and five patients with upper gastrointestinal bleeds secondary to tumors were recruited. The median Blatchford score at baseline was 10 (interquartile range [IQR], 7-12). The median Rockall score was 8 (IQR, 7-9). Immediate hemostasis was achieved in 102/105 (97%) patients, 15% of patients had a 30-day rebleed, 20% of patients died within 30 days (all-cause mortality). There was a significant improvement in transfusion requirements following treatment (P < 0.001) when comparing the number of units transfused 3 weeks before and after treatment. The mean reduction was one unit per patient. CONCLUSIONS: Hemospray achieved high rates of immediate hemostasis, with comparable rebleed rates following treatment of tumor-related upper gastrointestinal bleeds. Hemospray helped in improving transfusion requirements in these patients. This allows for patient stabilization and bridges towards definitive surgery or radiotherapy to treat the underlying tumor.

Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry.

BACKGROUND: Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % - 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy. METHODS: Data were collected prospectively (January 2016 - March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist's discretion. RESULTS: 202 patients with UGIB secondary to peptic ulcers were recruited. Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications. CONCLUSIONS: This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers.

Outcomes of Hemospray therapy in the treatment of intraprocedural upper gastrointestinal bleeding post-endoscopic therapy.

INTRODUCTION: With increasing advances in minimally invasive endoscopic therapies and endoscopic resection techniques for luminal disease, there is an increased risk of post-procedure bleeding. This can contribute to significant burden on patient's quality of life and health resources when reintervention is required. Hemospray (Cook Medical, North Carolina, USA) is a novel haemostatic powder licensed for gastrointestinal bleeding. The aim of this single-arm, prospective, non-randomised multicentre international study is to look at outcomes in patients with upper gastrointestinal bleeds following elective endoscopic therapy treated with Hemospray to achieve haemostasis. METHODS: Data was prospectively collected on the use of Hemospray from 16 centres (January 2016-November 2019). Hemospray was used during the presence of progressive intraprocedural bleeding post-endoscopic therapy as a monotherapy, dual therapy with standard haemostatic techniques or rescue therapy once standard methods had failed. Haemostasis was defined as the cessation of bleeding within 5 min of the application of Hemospray. Re-bleeding was defined as a sustained drop in haemoglobin (>2 g/l), haematemesis or melaena with haemodynamic instability after the index endoscopy. RESULTS: A total of 73 patients were analysed with bleeding post-endoscopic therapy. The median Blatchford score at baseline was five (interquartile range 0-9). The median Rockall score was six (interquartile range 5-7). Immediate haemostasis following the application of Hemospray was achieved in 73/73 (100%) of patients. Two out of 57 (4%) had a re-bleed post-Hemospray, one was following oesophageal endoscopic mucosal resection and the other post-duodenal endoscopic mucosal resection. Both patients had a repeat endoscopy and therapy within 24 h. Re-bleeding data was missing for 16 patients, and mortality data was missing for 14 patients. There were no adverse events recorded in association with the use of Hemospray. CONCLUSION: Hemospray is safe and effective in achieving immediate haemostasis following uncontrolled and progressive intraprocedural blood loss post-endoscopic therapy, with a low re-bleed rate.

Quality indicators for Barrett's endotherapy (QBET): UK consensus statements for patients undergoing endoscopic therapy for Barrett's neoplasia.

INTRODUCTION: Endoscopic therapy for the management of patients with Barrett's oesophagus (BE) neoplasia has significantly developed in the past decade; however, significant variation in clinical practice exists. The aim of this project was to develop expert physician-lead quality indicators (QIs) for Barrett's endoscopic therapy. METHODS: The RAND/UCLA Appropriateness Method was used to combine the best available scientific evidence with the collective judgement of experts to develop quality indicators for Barrett's endotherapy in four subgroups: pre-endoscopy, intraprocedure (resection and ablation) and postendoscopy. International experts, including gastroenterologists, surgeons, BE pathologist, clinical nurse specialist and patient representative, participated in a three-round process to develop 15 QIs that fulfilled the RAND/UCLA definition of appropriateness. RESULTS: 17 experts participated in round 1 and 20 in round 2. Of the 24 proposed QIs in round 1, 20 were ranked as appropriate (put through to round 2) and 4 as uncertain (discarded). At the end of round 2, a final list of 15 QIs were scored as appropriate. CONCLUSIONS: This UK national consensus project has successfully developed QIs for patients undergoing Barrett's endotherapy. These QIs can be used by service providers to ensure that all patients with BE neoplasia receive uniform and high-quality care.

Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray.

BACKGROUND AND AIM: Acute gastrointestinal bleeding carries poor outcomes unless prompt endoscopic hemostasis is achieved. Mortality in these patients remains significant. Hemospray is a novel intervention that creates a mechanical barrier over bleeding sites. We report the largest dataset of patient outcomes after treatment with Hemospray from an international multicenter registry. PATIENTS AND METHODS: Prospective data (Jan 2016-May 2018) from 12 centers across Europe were collected. Immediate hemostasis was defined as endoscopic cessation of bleeding within 5 min after application of Hemospray. Rebleeding was defined as subsequent drop in hemoglobin, hematemesis, persistent melena with hemodynamic compromise post-therapy. RESULTS: Three hundred and fourteen cases were recruited worldwide (231 males, 83 females). Median pretreatment Blatchford score was 11 (IQR: 8-14) and median complete Rockall score (RS) was 7 (IQR: 6-8) for all patients. Peptic ulcer disease (PUD) was the most common pathology (167/314 = 53%) and Forrest Ib the most common bleed type in PUD (100/167 = 60%). 281 patients (89.5%) achieved immediate hemostasis after successful endoscopic therapy with Hemospray. Rebleeding occurred in 29 (10.3%) of the 281 patients who achieved immediate hemostasis. Seven-day and 30-day all-cause mortality were 11.5% (36/314) and 20.1% (63/314), respectively (lower than the predicted rates as per the RS). Similar hemostasis rates were noted in the Hemospray monotherapy (92.4%), combination therapy (88.7%) and rescue therapy (85.5%) groups. CONCLUSIONS: These data show high rates of immediate hemostasis overall and in all subgroups. Rebleeding and mortality rates were in keeping/lower than predicted rates.

A prospective audit of the efficacy, safety, and acceptability of low-volume polyethylene glycol (2 L) versus standard volume polyethylene glycol (4 L) versus magnesium citrate plus stimulant laxative as bowel preparation for colonoscopy.

BACKGROUND: High-quality video colonoscopy requires adequate preparation of the bowel to ensure both adequate procedure completion rates and polyp detection rates. We sought to examine our practice to determine which bowel preparation cleansed most effectively in our patients. AIM: A prospective audit of the efficacy, safety, and acceptability of low-volume polyethylene glycol (2-L Moviprep; Norgine Pharmaceuticals) versus standard volume polyethylene glycol (4-L KleanPrep; Norgine Pharmaceuticals) versus magnesium citrate (Citramag; Sanochemia UK Ltd.) plus stimulant laxative as bowel preparation for colonoscopy. SETTING: District General Hospital. PATIENTS: Patients attending for day case colonoscopy. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Overall cleansing grades of preparations used: patient compliance, taste, and acceptability. METHODS: A prospective audit of patient experience of taking bowel preparation and blinded colonic scoring assessment of bowel cleansing of each of the tested regimes. RESULTS: A total of 258 (female,138; 53.5%) patients were recruited, 91 in the KleanPrep group (F:45, 49.5%), 86 patients in the Moviprep group (female, 45; 52.3%), and 81 in the Senna/Citramag group (female, 44; 54.3%). Significantly more patients were unable to take the prescribed dose of KleanPrep when compared with the other 2 regimes (19.6%; P<0.0001 vs. Moviprep; P<0.0001 vs. Senna/Citramag). A total of 45.65% of patients reported KleanPrep as tasting unpleasant. This was significantly more than both Moviprep (10.47%; P=0.008) and Senna/Citramag (9.88%; P<0.0001). The overall cleansing efficacy across the 3 groups (those with grades A or B) was 73.9%, 74.5%, and 86.5% for KleanPrep, Moviprep, and Senna/Citramag, respectively. In this series Senna/Citramag proved significantly better at bowel cleansing than KleanPrep (P<0.05) and it showed a trend toward better cleansing when compared with Moviprep (P=0.08). LIMITATIONS: Nonrandomized trial. Split-dosing regime for morning and afternoon lists may have confounded results. CONCLUSIONS: In summary, low-volume PEG (Moviprep) and Senna/Citramag combination were better tolerated than large volume PEG with Senna/Citramag providing superior mucosal cleansing.

Impact of nutritional factors on survival in patients with inoperable oesophageal cancer undergoing self-expanding metal stent insertion.

BACKGROUND: Undernutrition has been shown to be predictive of 30-day mortality in patients undergoing self-expanding metal stent (SEMS) insertion for inoperable oesophageal cancer. The aim of this study was to assess the relationship between nutritional factors and 30-day mortality in patients undergoing SEMS insertion for palliation of oesophageal cancer. METHODS: A retrospective cohort study was conducted from April 2007 to June 2009. BMI, swallowing ability, calorific intake and nature of nutritional support were recorded. ICD-10 causes of death were obtained from the Department of Health and Social Services. RESULTS: Fifty-six stents were inserted into 53 patients (mean age 70 years, male n=35). Median (interquartile range) BMI was 21.0 kg/m (18.7-24.0). Median pre-SEMS swallowing grade was 3. Median calorific intake as a percentage of estimated daily requirements was 94.0% (75.6-100.0%). Thirty (56.6%) patients tolerated an oral diet enhanced with supplement drinks whereas 23 (43.4%) patients required more invasive forms of enteral and parenteral support. The 30-day mortality rate was 11.3% (n=6) and cumulative median survival was 84 (interquartile range 38-156) days. BMI, calorific intake and swallowing capacity were not predictors of survival. Although there was a nonsignificant trend for reduced survival in those patients who did (n=23) receive invasive nutritional support compared with those who did not (n=30) (83.9 vs. 151.3 days, P=0.053), invasive nutritional support itself was not predictive of 30-day mortality (P=0.74). CONCLUSION: The requirement for invasive nutritional support before SEMS insertion is associated with a poor prognosis and possibly represents more aggressive tumour pathology. Further prospective assessment of prognostic factors, including nutritional parameters, to facilitate reliable selection of appropriate palliative modalities in oesophageal cancer is required.

Nicorandil associated colonic ulceration: case series of an increasingly recognized complication.

BACKGROUND: Nicorandil is widely accepted in the therapeutic armamentarium of ischemic heart disease and, although nicorandil-induced oral and anal ulcerations have been established in the literature, only five cases have reported the possibility of nicorandil-induced ulceration elsewhere in the gastrointestinal tract. There have been recent case reports which have suggested the possible causative association between nicorandil and colonic ulceration, either in isolation or in combination with anal ulceration. METHODS: We report a case series of eight patients prescribed with nicorandil therapy presenting with gastrointestinal symptoms and subsequently diagnosed with colonic ulceration on colonoscopy. RESULTS: Eight patients were identified (five female, three male). Colonoscopic findings varied from solitary to multiple colonic ulcers. No concomitant oral or anal ulcerations were noted in these patients. Biopsies from the ulcers showed only non-specific inflammation. Cessation of nicorandil therapy resulted in resolution of symptoms and complete healing of colonic ulcers. CONCLUSION: Nicorandil therapy appears to be an emerging etiology in the development of idiopathic colonic ulceration and therefore should be considered as a differential diagnosis in a selected group of patients.

High resolution manometry and multichannel intraluminal impedance oesophageal manometry in clinical practice.

The past decade has seen new technological advances in the investigation of oesophageal motility disorders. Multichannel intraluminal impedance monitoring has been used as an adjunct to conventional manometry in the assessment of oesophageal function, independent of radiography. High resolution manometry provides additional information over conventional manometry, and its topographic analysis makes interpretation of studies easier. Both utilities in non-obstructive dysphagia have been used ultimately in research; however, more studies are addressing their clinical application.

Nonacid reflux episodes reaching the pharynx are important factors associated with cough.

BACKGROUND: Gastroesophageal reflux is implicated in the pathogenesis of asthma and chronic cough. To date most studies have focused on acid reflux measured by pH below the upper esophageal sphincter (UES). The aim of this study was to assess the relationship between cough and reflux through the UES into the pharynx. METHODS: Thirty-seven patients with asthma (19) and chronic cough (18) were recruited from the respiratory clinic. Reflux was monitored using a combined multichannel intraluminal impedance and pH probe by detecting (1) bolus reflux episodes within the esophagus and in the pharynx and (2) acidic reflux episodes within the esophagus and in the pharynx. All acid suppressive therapy was stopped for at least 7 days before the study. Demonstration of cough being linked to reflux was achieved using the symptom association probability (SAP). This was calculated using a 2-minute association window between symptoms and bolus entry into the esophagus. SAP was considered positive if >95%. RESULTS: A positive SAP for cough was noted in 7/26 patients reporting symptoms on the day of monitoring. Compared with SAP-negative patients, SAP-positive patients had both a greater number [median (interquartile range), 5(2 to 8) vs. 2(0 to 4), P<0.05] and a higher proportion of reflux episodes crossing the UES into the pharynx [25%(14% to 28%) vs. 7% (2% to 14%), P<0.02]. There was no difference in the number of reflux episodes or acid exposure time in the distal esophagus between SAP-positive and SAP-negative patients. Only 1% to 2% of episodes were detected by the pharyngeal pH sensor. CONCLUSIONS: Impedance detected pharyngeal reflux episodes are important factors in symptom production in cough patients.

Addition of a H2 receptor antagonist to PPI improves acid control and decreases nocturnal acid breakthrough.

BACKGROUND: The addition of a bedtime H2 receptor antagonist (H2RA) to proton pump inhibitor (PPI) b.i.d. to inhibit nocturnal acid breakthrough (NAB) is controversial. H2RA tolerance has been documented suggesting limitations in its long-term effect. AIM: To compare the intragastric pH and NAB occurring with twice daily PPI with or without the addition of a H2RA. METHOD: Multichannel intraluminal impedance-pH studies in 100 patients were reviewed. Fifty-eight patients (female 41; mean age, 54 y; range, 17 to 85) were studied on twice daily PPI. Forty-two patients (female 36; mean age, 53 y; range 20 to 85) were studied on a PPI b.i.d.+H2RA for at least 1 month at bedtime. The percentage time of intragastric pH<4 (upright, recumbent, and total) and NAB were compared between the groups. RESULTS: In the patients with PPI b.i.d. 64% had NAB, compared with only 17% of patients on PPI b.i.d. and H2RA q.h.s. (P<0.001). The percent time intragastric pH<4 for patients on PPI b.i.d. was significantly higher (P<0.01) compared with patients on PPI b.i.d.+H2RA q.h.s. during upright (29.1+/-3.0 vs. 18.3+/-2.9), recumbent (33.5+/-3.4 vs. 12.5+/-3.1), and entire period (31.5+/-2.8 vs. 18.0+/-3.0). CONCLUSIONS: The addition of a bedtime H2RA reduces the percentage time of the intragastric pH<4 and also NAB. H2RA should be considered as adjunct therapy in whom greater suppression of gastric acid control is considered desirable.