Prophylactic clipping to prevent delayed colonic post-polypectomy bleeding: meta-analysis of randomized and observational studies
Surgical endoscopy. 2021
BACKGROUND AND AIMS Delayed post-polypectomy bleeding (DPPB) is a commonly described adverse event following polypectomy. Prophylactic clipping may prevent DPPB in some patient subgroups. We performed a meta-analysis to assess both the efficacy and real-world effectiveness of prophylactic clipping. METHODS We performed a database search through March 2020 for clinical trials or observational studies assessing prophylactic clipping and DPPB. Pooled risk ratios (RR) were calculated using random effects models. Subgroup, sensitivity, and meta-regression analyses were performed to elucidate clinical or methodological factors associated with effects on outcomes. RESULTS A total of 2771 citations were screened, with 11 randomized controlled trials (RCTs) and 9 observational studies included, representing 24,670 colonoscopies. DPPB occurred in 2.0% of patients overall. The pooled RR of DPPB was 0.47 (95% CI 0.29-0.77) from RCTs enrolling only patients with polyps ≥ 20 mm. Remaining pooled RCT data did not demonstrate a benefit for clipping. The pooled RR of DPPB was 0.96 (95% CI 0.61-1.51) from observational studies including all polyp sizes. For patients with proximal polyps of any size, the RR was 0.73 (95% CI 0.33-1.62) from RCTs. Meta-regression confirmed that polyp size ≥ 20 mm significantly influenced the effect of clipping on DPPB. CONCLUSION Pooled evidence demonstrates a benefit when clipping polyps measuring ≥ 20 mm, especially in the proximal colon. In lower-risk subgroups, prophylactic clipping likely results in little to no difference in DPPB.
Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial
The Journal of urology. 2021;:101097ju0000000000001586
PURPOSE Erectile dysfunction significantly impacts quality of life for men undergoing radical prostatectomy (RP) for prostate cancer. Erythropoietin is a promising neurotrophic factor for neurogenic erectile dysfunction based on preclinical and retrospective data. MATERIALS AND METHODS ERECT (NCT00737893) is a phase 2, double-blinded, randomized placebo-controlled trial (July 2017-December 2019) evaluating the impact of perioperative erythropoietin on recovery of erectile function and other patient-reported, health-related quality of life outcomes after bilateral nerve-sparing RP (3, 6, 9, and 12-months). Erythropoietin (20,000 units) or saline placebo was injected subcutaneously the day before, day of, and day after surgery for 3 total doses. RESULTS Of 63 patients assessed for eligibility, 56 patients were randomized. Arms (29 erythropoietin, 27 placebo) were well-balanced (89.3% robotic, median age 55.5 years). IIEF-EF scores increased from median 12.5 at 3-months to 24.5 at 12-months. Median 2-week serum hemoglobin was higher for the erythropoietin arm compared to placebo (14.7 vs. 13.6, p=0.02). There was no statistically significant difference in IIEF-EF scores at 6-months comparing erythropoietin to placebo (p=0.50) or at other timepoints (mixed model regression coefficient: -1.7 (95%CI -6.1-2.7, p=0.45). Excellent nerve-sparing rating (10/10) was associated with improved IIEF-EF recovery (+5.2, p=0.022). Other patient-reported, health-related quality of life domains as well as oncologic outcome and complications were similar between arms during follow-up. CONCLUSIONS In the context of brief perioperative dosing, erythropoietin did not improve recovery of erectile function for men undergoing RP for prostate cancer compared to placebo. Further research to identify effective adjuncts to improve health-related quality of life for these men is needed.
Role of prophylactic hemoclip placement in prevention of delayed post-polypectomy bleeding for large colon polyps: a meta-analysis of randomized controlled trials
Annals of gastroenterology. 2021;34(3):392-398
BACKGROUND Polypectomy is a widely used and effective procedure to treat precancerous polyps. Delayed post-polypectomy bleeding (DPPB), a common complication of polypectomy, may diminish the utility of this procedure. Previous data on the efficacy of hemoclips has been conflicting, therefore we aimed to collectively evaluate and analyze the data to reach a definitive conclusion on the efficacy of using hemoclips to prevent incidences of DPPB in patients with large polyps (≥10 mm). METHODS We identified a total of 261 studies based on our previously defined search strategy. After screening, we included 6 randomized controlled trials. A meta-analysis was performed comparing the use of prophylactic application of hemoclips to a standard group without prophylactic clip placement for large polyps. RESULTS We found a statistically significant reduction in the incidence of DPPB when using hemoclips for large polyps. The overall incidence of DPPB was lower in the hemoclip group compared to the standard group for all large polyps ≥10 mm (relative risk 0.51, 95% confidence interval 0.35-0.75; P=0.01; I (2)=0%). CONCLUSIONS The use of hemoclips in achieving hemostasis for large polyps has a beneficial effect and appears to prevent DPPB. This reinforces the routine clinical practice of using hemoclips in polypectomy procedures.
Potentially Overestimated Efficacy of Nanoparticle Albumin-bound Paclitaxel compared with Solvent-based Paclitaxel in Breast Cancer: A Systemic Review and Meta-analysis
Journal of Cancer. 2021;12(17):5164-5172
Background: Nanoparticle albumin-bound paclitaxel (nab-PTX) has exhibited clinical efficacy in breast cancer treatment, but toxicities can be yielded more at the same time. We did this meta-analysis aiming to unambiguously compare nab-PTX with conventional solvent-based paclitaxel (sb-PTX) in breast cancer patients of all stages. Method: Pubmed, Embase and Cochrane Library were searched for head-to-head randomized controlled trials of nab-PTX and sb-PTX in breast cancer. Risk ratio (RR) with 95% confidence interval was used for dichotomous variables while Hazard ratio (HR) was used for time-to-event outcomes. Results: Our review finally included 9 studies with 3508 patients. Nab-PTX showed a benefit on objective response rate (ORR) (RR=1.22 [1.04-1.43], P=0.01) as well as non-inferiority compared with sb-PTX in disease control rate (DCR) (RR=1.01 [0.98-1.04], P=0.44), overall survival (OS) (HR=0.99 [0.93-1.05], P=0.81) and disease free survival/progression free survival (DFS/PFS) (HR=0.92 [0.81-1.05], P=0.21). However, when it comes to toxicities (fatigue, nausea or vomiting, peripheral sensory neuropathy and adverse event related discontinuation), results favored sb-PTX (RR=2.89 [1.07-7.8], 3.15 [1.78-5.59], 2.11 [1.32-3.37], 2.02 [1.61-2.53]; P<0.05). Patients with metastatic tumors or undergoing conventional schedule responses better to nab-PTX than the compared groups (RR of ORR in metastatic vs early or locally advanced patients: 1.46 [1.09-1.96] vs 1.01 [0.94-1.08]; conventional vs dose dense group: 1.59 [1.23-2.06] vs 1.01 [0.91-1.12]). Conclusions: Nab-PTX can improve ORR compared with paclitaxel and should be given priority to when aiming to reduce tumor load in breast cancer. Sb-PTX of dose dense schedule is recommended when toxicity of nab-PTX is hard to bear for breast cancer patients.
Palliative radiotherapy for gastric cancer: Is there a dose relationship between bleeding response and radiotherapy?
Clinics (Sao Paulo, Brazil). 2020;75:e1644
The aim of this study was to evaluate whether there is a relationship between bleeding response and radiotherapy dose to palliate patients with local recurrence or progression of gastric cancer (GC). To this end, we conducted a systematic review and meta-analysis of observational studies that evaluated the bleeding response in patients with GC with local recurrence or progression. A meta-regression analysis between biological effective dose (BED) and bleeding response was performed, as was subgroup analysis to evaluate the outcome by BED level and radiotherapy (RT) technique. A p-value <0.05 was considered significant. Ten non-comparative retrospective studies and one prospective study were included. In general, RT was effective at controlling tumor bleeding, and the bleeding response rate was 0.77 (95% confidence interval (CI), 0.73-0.81). Meta-regression analysis demonstrated a linear correlation between BED Gy 10 and bleeding response (p=0<0001). Studies using conformational RT had a significant bleeding response rate compared to those using 2D (0.79; 95%CI, 0.74-0.84 vs 0.65; 95%CI, 0.56-0.75; p=0.021). In terms of the BED level, a significant difference in BR was identified on comparing BED Gy10 ≥40 (0.79; 95%CI, 0.7-0.8), BED Gy10 30-39 (0.79, 95%CI, 0.71-0.86), and BED Gy10 <30 (0.64; 95%CI, 0.5-0.7; p=0.0001). The mean survival time was 3.31 months (95%CI, 2.73-3.9) months, and the responders had a significantly longer survival (longer by 2.5 months) compared to the non-responders (95%CI, 1.7-3.3; p<0.0001). Palliative RT is effective at controlling bleeding due to local recurrence/progression from GC. Our findings reveal a relationship between BR and BED. BED <30 Gy 10 should not be recommended, and 3DRT should be indicated instead in order to improve the result.
A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial
BACKGROUND Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. METHODS This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. RESULTS There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). CONCLUSIONS This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.
The Effects of Hyperbaric Oxygen Therapy on Pelvic Radiation Induced Gastrointestinal Complications (Rectal Bleeding, Diarrhea, and Pain): A Meta-Analysis
Front Oncol. 2020;10:390
Background: Radiotherapy is a routine treatment for pelvic cancer patients. While it had been proven effective, gastrointestinal side effects remain a concern, impairing the quality of life. A few studies focused on the effects of hyperbaric oxygen (HBO) treatment to alleviate radiation-induced gastrointestinal complications. This meta-analysis aimed to critically review and summarize existing literature, assessing the effectiveness of HBO therapy for the treatment of radiation-induced gastrointestinal side effects. Methods: Medical literature search was performed with PubMed, Cochrane Library, and EMBASE up to March 14, 2019. Literatures about HBO treatment upon patients undergoing pelvic cancer (endometrial, cervix, rectum, or prostate cancers) radiotherapy were collected, and the effects of HBO treatment on radiotherapy-induced gastrointestinal complications were evaluated. A random-effects model was used to calculate the pooled effect size. Subgroup analyses were performed to search for sources of heterogeneity. Publication bias was detected with Funnel plots and Egger's test. Results: Three different radiotherapy-related gastrointestinal complications, including rectal bleeding, diarrhea, and pain, were analyzed after screening. It was revealed that the improvement rates were considerable in rectal bleeding (0.81, 95% CI: 0.74-0.89) and diarrhea (0.75, 95% CI: 0.61-0.90) and slightly in pain (0.58, 95% CI: 0.38-0.79). Subgroup analysis revealed factors that significantly influenced the heterogeneity of rectal bleeding, diarrhea, and pain (evaluation criteria, follow-up time, and scoring system, respectively). No significant publication bias was detected. Conclusion: HBO treatment might have the potential to alleviate radiotherapy-related gastrointestinal complications, including rectal bleeding, diarrhea, and pain, but more data are needed for further conclusions. Other symptoms were not further analyzed, as the number of studies was insufficient. More large-scale and prospective studies are needed for better evaluation of HBO's therapeutic values.
Transcatheter arterial embolization for intractable, nontraumatic bladder hemorrhage in cancer patients: a single-center experience and systematic review
Japanese journal of radiology. 2020
PURPOSE To explore the effect of transcatheter arterial embolization (TAE) in controlling intractable, nontraumatic bladder hemorrhage in cancer patients. MATERIALS AND METHODS A literature review (PubMed and EMBASE), followed by a retrospective analysis of all cancer patients with intractable hematuria from bladder treated by TAE at our tertiary referral center. RESULTS At our institution, 27 consecutive cancer patients who underwent TAE for refractory hematuria from bladder were identified. The systematic review included 13 studies published between 1981 and 2019. In our local cohort, 27 patients were treated with 100% technical success, clinical success in 88.9%, no major complications, and rebleeding rate within the first month of 7.4%. In the systematic review cohort of 201 patients, there was technical success in 99.0%, clinical success in 80.9%, major complications in 5.5%, and a rebleeding rate within the first month of 4.5%. Bilateral embolization was performed in 81.1%, and embolization levels were mostly anterior division of internal iliac artery (73.7%) and vesical artery (23.2%). CONCLUSION TAE is effective and safe to control intractable hematuria from bladder origin in cancer patients after failure of conservative management, providing effective temporary hemostasis. For bladder hemorrhage unsuitable for surgery, TAE should be considered at an early stage. A literature review, followed by retrospective analysis of all patients with intractable hematuria from bladder treated by transcatheter arterial embolization at our tertiary referral center. Transcatheter arterial embolization is effective and safe to control intractable hematuria from bladder. The major complication rate and rebleeding within the first month are acceptable.
Hyperfibrinolysis in Patients with Solid Malignant Neoplasms: A Systematic Review
Seminars in thrombosis and hemostasis. 2020
Solid malignant neoplasms have the capability of disturbing the fibrinolytic system, leading to primary hyperfibrinolysis, a paraneoplastic syndrome that potentially results in severe bleeding. Yet, the full extent of primary hyperfibrinolysis in solid malignant neoplasms is unknown. Thus, the purpose of this study was to systematically review the current literature regarding clinical manifestations, biochemical diagnosis, and treatment of primary hyperfibrinolysis in patients with solid malignant neoplasms. The review was performed in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The databases PubMed, Embase, Scopus, and Web of Science were searched on December 5, 2019, without time limits. Studies were included if they comprised at least one biochemical marker of fibrinolysis in addition to fibrinogen degradation products such as D-dimer, and furthermore included a correlation between biochemical marker and clinical outcome. In total, 12 studies were included. All studies were case reports including a total of 21 patients. Prostate cancer was the most frequently represented cancer type (76%), and the majority of cancer patients had metastatic disease (81%). Spontaneous bleeding was the clinical presentation in the majority of patients (76%), and the most frequently localization for the bleedings was subcutaneous. Antifibrinolytic agents were the most commonly used treatment and ceased bleedings in 80% of patients. Three patients died of uncontrolled bleedings. In conclusion, primary hyperfibrinolysis induced by solid malignant neoplasms is a rare but potentially life-threatening condition that should be considered, especially in patients with metastatic disease presenting with serious, spontaneous subcutaneous bleedings. A standardized diagnostic strategy is strongly needed.
Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis
Scientific reports. 2020;10(1):530
The curative effects of nanoparticle albumin-bound (nab)-paclitaxel in the first-line treatment of metastatic breast cancer (MBC) are still controversial, with even more after the removal of marketing approval of indication of bevacizumab. Five electronic databases and the related resources were searched for eligible randomized clinical trials (RCTs) without year and language restrictions to perform a meta-analysis. The studies were comparing the efficacy and safety between nab-paclitaxel chemotherapy versus solvent-based (sb)-taxanes chemotherapy such as sb-paclitaxel and docetaxel. The primary end points were overall response rate (ORR) and disease control rate (DCR). Secondary end points were progression-free survival (PFS), overall survival (OS), adverse events (AEs), and dose discontinuation rate (DDR). Five RCTs (1,554 patients) were finally identified from 1,902 studies. When compared to sb-paclitaxel, nab-paclitaxel showed significant beneficial effects in terms of ORR (OR 2.39, 95% CI 1.69-3.37, p < 0.001), DCR (OR 1.89, 95% CI 1.07-3.35, p = 0.03), and PFS (HR 0.75, 95% CI 0.62-0.90, p = 0.002). Nab-paclitaxel also showed significantly longer OS (HR 0.73, 95% CI 0.54-0.99, p = 0.04) than docetaxel. AEs and DDR were comparable between the two arms. Using nab-paclitaxel could significantly improve efficacy with comparable toxicities in the treatment of MBC.
Patients with metastatic breast cancer, (5 studies), (n= 1,554).
Nanoparticle albumin-bound (nab)-paclitaxel chemotherapy, (n=774).
Solvent-based (sb)-taxanes chemotherapy: sb-paclitaxel, (n=606) and docetaxel, (n=174).
When compared to sb-paclitaxel, nab-paclitaxel showed significant beneficial effects in terms of overall response rate (ORR) (OR 2.39), disease control rate (DCR) (OR 1.89), and progression-free survival (PFS) (HR 0.75). Nab-paclitaxel also showed significantly longer overall survival (OS) (HR 0.73) than docetaxel. Adverse events (AEs) and dose discontinuation rate (DDR) were comparable between the two arms.