1.
Hemostatic spray (TC-325) vs. standard endoscopic therapy for non-variceal gastrointestinal bleeding: A meta-analysis of randomized controlled trials
Deliwala SS, Chandan S, Mohan BP, Khan S, Reddy N, Ramai D, Bapaye JA, Dahiya DS, Kassab LL, Facciorusso A, et al
Endoscopy international open. 2023;11(3):E288-e295
Abstract
Background and study aims Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Methods Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I (2) %. Results Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I (2) 43), P = 0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I (2) 35), P = 0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I (2) 0), P = 0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I (2) 0), P = 0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I (2) 26), P = 0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I (2) 62), P = 0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I (2) 0), P = 0.02. Conclusions Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.
2.
A systematic review and meta-analysis of safety and efficacy of over the scope clips versus standard therapy for high-risk non-variceal upper gastrointestinal bleeding
Bapaye J, Chandan S, Naing LY, Shehadah A, Deliwala S, Bhalla V, Chathuranga D, Okolo PI 3rd
Gastrointestinal endoscopy. 2022
Abstract
BACKGROUND AND AIMS Upper gastro-intestinal bleeding is a common condition associated with significant morbidity and mortality. Endoscopic hemostasis remains the mainstay of therapy and is mainly aimed at effective hemostasis and prevention of rebleeding. Lesions with high-risk stigmata can have rebleeding rates of as high as 26.3%. Rebleeding is associated with increased mortality and reduced success rates of endoscopic retreatment. The over-the-scope-clip (OTSC) is a device with widespread endoscopic indications including hemostasis for non-variceal upper GIB (NVUGIB). The current study presents a systematic review and meta-analysis comparing OTSC versus standard therapy (STD) for NVUGIB. METHODS Multiple databases were searched through April 2022 for studies comparing OTSC and standard therapy for NVUGIBs. The primary outcomes were clinical success rates, rebleeding rates, procedure times and secondary outcomes were mortality rates and length of hospitalization. Meta-analysis was performed to determine pooled odds ratios (ORs) to compare outcomes between the OTSC and standard therapy groups. RESULTS Ten studies, including four randomized controlled trials, with 914 patients were included in the final analysis. 431 patients with NVUGIB's were treated with OTSC and 483 patients were treated with STD. Patients treated with OTSC had an overall lower risk of 7-day (RR 0.41 (95% CI 0.24-0.68, I(2) = 0%)) and 30-day rebleeding (RR 0.46 (95% CI 0.31-0.65, I(2) = 0%)). Clinical success rates were higher with OTSC compared with STD (RR 1.36 (95% CI 1.06 - 1.75. Mean procedure time was shorter in the OTSC group by 6.62 min (95% CI 2.58 - 10.67) vs STD therapy. I(2) = 84%. There was no statistically significant difference in terms of mortality between the OTSC and STD groups, RR 0.55 (95% CI 0.24-1.24, I(2) = 0%). Length of hospitalization was comparable between both groups with the pooled mean difference for OTSC vs STD being 0.87 d (-1.62 d - 3.36 d, I(2) = 71%). CONCLUSIONS While our study is limited to high-risk NVUGIB's, our analysis shows that hemostasis with OTSC is associated with a lower 7-day and 30-day rebleeding rate, higher clinical success rates and shorter procedure time with similar mortality rates and length of hospital stay as compared to standard therapy.
3.
Effectiveness of hemostatic powders in lower gastrointestinal bleeding: a systematic review and meta-analysis
Facciorusso A, Bertini M, Bertoni M, Tartaglia N, Pacilli M, Ramai D, Mohan BP, Chandan S, Ambrosi A, Sacco R
Endoscopy international open. 2021;9(8):E1283-e1290
Abstract
Background and study aims There is limited evidence on the effectiveness of hemostatic powders in the management of lower gastrointestinal bleeding (LGIB). We aimed to provide a pooled estimate of their effectiveness and safety based on the current literature. Patients and methods Literature review was based on computerized bibliographic search of the main databases through to December 2020. Immediate hemostasis, rebleeding rate, adverse events, and mortality were the outcomes of the analysis. Pooled effects were calculated using a random-effects model. Results A total of 9 studies with 194 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %-98.5 %), with no difference based on treatment strategy or bleeding etiology. Pooled 7- and 30-day rebleeding rates were 10.9 % (95 %CI 4.2 %-17.6 %) and 14.3 % (95 %CI 7.3 %-21.2 %), respectively. Need for embolization and surgery were 1.7 % (95 %CI 0 %-3.5 %) and 2.4 % (95 %CI 0.3 %-4.6 %), respectively. Overall, two patients (1.9 %, 95 %CI 0 %-3.8 %) experienced mild abdominal pain after powder application, and three bleeding-related deaths (2.3 %, 95 %CI 0.2 %-4.3 %) were registered in the included studies. Conclusion Novel hemostatic powders represent a user-friendly and effective tool in the management of lower gastrointestinal bleeding.
4.
Self-expanding metal stents versus TIPS in treatment of refractory bleeding esophageal varices: a systematic review and meta-analysis
Mohan BP, Chandan S, Khan SR, Kotagiri R, Kassab LL, Olaiya B, Ponnada S, Ofosu A, Adler DG
Endoscopy International Open. 2020;8(3):E291-e300
Abstract
Background and study aims Refractory and recurrent esophageal variceal (EV) bleeding can be life threatening. Self-expanding metal stents (SEMS) have been used as a "bridge" therapy. However, their role in the treatment protocol is not established due to paucity in data. Methods We searched multiple databases from inception through May 2019 to identify studies that reported on SEMS and TIPS in refractory EV hemorrhage. Our primary goals were to analyze and compare the pooled all-cause mortality, immediate bleeding control and rebleeding rates. Results Five hundred forty-seven patients from 21 studies were analyzed (SEMS: 12 studies, 176 patients; TIPS 9 studies, 398 patients). The pooled rate of all-cause mortality with SEMS was 43.6 % (95 % CI 28.6-59.8, I (2) = 38) and with TIPS was 27.9 % (95 % CI 16.3-43.6, I (2) = 91). The pooled rate of immediate bleeding control with SEMS was 84.5 % (95 % CI 74-91.2, I (2) = 40) and with TIPS was 97.9 % (95 % CI 87.7-99.7, I (2) = 0). The pooled rate of rebleeding with SEMS was 19.4 % (95 % CI 11.9-30.4, I (2) = 32) and with TIPS was 8.8 % (95 % CI 4.8-15.7, I (2) = 40). Conclusion Use of SEMS in refractory EV hemorrhage demonstrates acceptable immediate bleeding control with good technical success rate. Mortality and rebleeding rates were lesser with TIPS, however, its superiority and/ or inferiority cannot be validated due to limitations in the comparison methodology.