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Carlo Corbellini - One of the best experts on this subject based on the ideXlab platform.

  • Multicentric GISCoR Study “Intensive clinical follow-up versus surgical radicalization after complete Endoscopic Polypectomy of a malignant adenoma” (SEC-GISCoR)
    Updates in Surgery, 2011
    Co-Authors: Bruno Andreoni, Lorenzo Camellini, Angelica Sonzogni, Cristiano Crosta, Maria Elena Pirola, Carlo Corbellini
    Abstract:

    Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study “Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy” (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete Endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after “complete” Endoscopic Polypectomy; malignant polyps were classified as “low risk” or “high risk”. The study had two arms: “Intensive follow-up” (42 patients: 32 with low-risk and 10 with high-risk polyps) and “Surgical radicalization” (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the “clinical follow-up” arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers ( p  

  • multicentric giscor study intensive clinical follow up versus surgical radicalization after complete Endoscopic Polypectomy of a malignant adenoma sec giscor
    Updates in Surgery, 2011
    Co-Authors: Bruno Andreoni, Lorenzo Camellini, Angelica Sonzogni, Cristiano Crosta, Maria Elena Pirola, Carlo Corbellini
    Abstract:

    Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study “Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy” (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete Endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after “complete” Endoscopic Polypectomy; malignant polyps were classified as “low risk” or “high risk”. The study had two arms: “Intensive follow-up” (42 patients: 32 with low-risk and 10 with high-risk polyps) and “Surgical radicalization” (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the “clinical follow-up” arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers (p < 0.001), mismatches can be explained by high surgical risk or patient’s choice. Only in 5 cases (4.2%), did data analysis not allow to exactly determine the reason for a choice different from protocol criteria. The availability of new risk factors and the evidence of pathological mismatches confirmed the need for future studies on this issue.

Shaun Kilty - One of the best experts on this subject based on the ideXlab platform.

  • Endoscopic Polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps study protocol for the epic multicentre randomised controlled trial
    BMJ Open, 2020
    Co-Authors: Kednapa Thavorn, Shaun Kilty, Arif Janjua, John M Lee, Kristian I Macdonald, Eric Meen, Damian Christopher Micomonaco
    Abstract:

    Introduction Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and Endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, Endoscopic Polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of Polypectomy or ESS for the management of CRSwNP. Methods and analysis We designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire. We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period. Ethics and dissemination This study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board. Trial registration number NCT02975310.

  • Cost-effectiveness of Endoscopic Polypectomy in Clinic compared to Endoscopic Sinus Surgery: A modelling study.
    Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery, 2020
    Co-Authors: Srishti Kumar, Kednapa Thavorn, Sasha Van Katwyk, Andrea Lasso, Shaun Kilty
    Abstract:

    OBJECTIVE To compare costs and quality-adjusted life years of patients receiving Endoscopic Polypectomy in the clinic those receiving Endoscopic sinus surgery from the perspective of Canada's health system. METHOD We developed a Markov model to simulate costs and quality-adjusted life years among a cohort of patients with chronic rhinosinusitis with polyps who received Endoscopic Polypectomy in clinic or Endoscopic sinus surgery, over a patient's lifetime. Our study focused on patients with chronic rhinosinusitis with polyps who have the predominant symptom of bilateral nasal obstruction. Cost data were obtained from Canadian sources. Health utility values were derived from Sino-nasal Outcome Test (SNOT-22) scores reported in the published literature. A cycle length of six months was used. Both costs and quality-adjusted life years were discounted using an annual rate of 1.5%. We conducted one-way and probabilistic sensitivity analyses to assess the robustness of the study findings. RESULTS Endoscopic Polypectomy in clinic was a cost-saving option as it had a lower cost (C$736 vs. C$6,728) and produced more quality-adjusted life years (13.85 vs 13.06) compared to Endoscopic sinus surgery. Our findings were, however, highly sensitive to health utility values. Results from probabilistic sensitivity analysis showed that Endoscopic Polypectomy in clinic had a lower cost and was more effective compared to Endoscopic sinus surgery in 99.86% of iterations. CONCLUSION From the perspective of the publicly funded healthcare system, Endoscopic Polypectomy in clinic was economically attractive compared to Endoscopic sinus surgery for chronic rhinosinusitis with polyps patients who have a primary symptom of bilateral nasal obstruction. The cost-effectiveness results are, however, highly dependent on the relative impact of Endoscopic Polypectomy in the clinic and Endoscopic sinus surgery on post-surgery health utility values.

  • case control study of Endoscopic Polypectomy in clinic epic versus Endoscopic sinus surgery for chronic rhinosinusitis with polyps
    Rhinology, 2018
    Co-Authors: Shaun Kilty, A Lasso, L Mfunaendam, Martin Desrosiers
    Abstract:

    Introduction Endoscopic Polypectomy In Clinic (EPIC) is a recently described deescalated form of Endoscopic sinus surgery (ESS) performed in the outpatient clinic for patients with chronic rhinosinusitis with polyps (CRSwNP). The quality of life benefit of EPIC in comparison to ESS is not known. The purpose of this study was to determine if the disease specific quality of life measured with the SNOT-22 attained with EPIC is similar to that attained with ESS for patients with CRSwNP. Methods A multi-institutional observational case-control study was performed to evaluate quality of life improvement in patients treated with ESS and EPIC for CRSwNP with a 3 month follow-up. Predicted probability of undergoing EPIC was calculated by fitting a logistic regression model using clinically relevant variables. EPIC patients were matched to ESS patients in a 1:1 fashion. Results 24 pairs were analyzed after matching. There was no statistical difference in the post-treatment SNOT-22 scores or proportion of patients achieving a minimal clinically important difference. Conclusions In appropriate CRSwNP patients, the EPIC procedure may provide disease specific quality of life improvement similar to that seen with patients who undergo traditional ESS.

  • Endoscopic Polypectomy in the clinic: a pilot cost-effectiveness analysis.
    Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery, 2016
    Co-Authors: Luke Rudmik, Kristine A. Smith, Shaun Kilty
    Abstract:

    Objective The purpose of this pilot economic evaluation was to assess the cost-effectiveness of the Endoscopic Polypectomy in the clinic (EPIC) procedure compared to formal Endoscopic sinus surgery (ESS) for the treatment of select chronic rhinosinusitis (CRS) patients with nasal polyposis. Design Cost-effectiveness analysis using a Markov decision tree model with a 30-year time horizon. The two comparative treatment groups were as follows: (i) EPIC and (ii) ESS. Costs and effects were discounted at a rate of 3.5%. A probabilistic sensitivity analysis was performed. Setting Economic perspective of the Canadian government third-party payer. Participants CRS patients with nasal polyposis who have predominantly isolated symptoms of nasal obstruction with or without olfactory loss. Main outcome measures Incremental cost per quality adjusted life year (QALY). Results Over a time period of 30 years, the reference case demonstrated that the ESS strategy cost a total of $21 345 and produced 13.17 QALYs while the EPIC strategy cost a total of $5591 and produced 12.93 QALYs. The ESS versus EPIC incremental cost-effectiveness ratio was $65 641/QALY. The probability that EPIC is cost-effective compared to ESS at a maximum willingness-to-pay threshold of $30 000 and $50 000/QALY is 66% and 60%, respectively. Conclusions Outcomes from this study have demonstrated that the EPIC procedure may be a cost-effective treatment strategy for ‘select’ patients with nasal polyposis. Data from this study were obtained from a small pilot trial, and we feel the results warrant a future randomised controlled trial to strengthen the outcomes.

Bruno Andreoni - One of the best experts on this subject based on the ideXlab platform.

  • Multicentric GISCoR Study “Intensive clinical follow-up versus surgical radicalization after complete Endoscopic Polypectomy of a malignant adenoma” (SEC-GISCoR)
    Updates in Surgery, 2011
    Co-Authors: Bruno Andreoni, Lorenzo Camellini, Angelica Sonzogni, Cristiano Crosta, Maria Elena Pirola, Carlo Corbellini
    Abstract:

    Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study “Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy” (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete Endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after “complete” Endoscopic Polypectomy; malignant polyps were classified as “low risk” or “high risk”. The study had two arms: “Intensive follow-up” (42 patients: 32 with low-risk and 10 with high-risk polyps) and “Surgical radicalization” (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the “clinical follow-up” arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers ( p  

  • multicentric giscor study intensive clinical follow up versus surgical radicalization after complete Endoscopic Polypectomy of a malignant adenoma sec giscor
    Updates in Surgery, 2011
    Co-Authors: Bruno Andreoni, Lorenzo Camellini, Angelica Sonzogni, Cristiano Crosta, Maria Elena Pirola, Carlo Corbellini
    Abstract:

    Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study “Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy” (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete Endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after “complete” Endoscopic Polypectomy; malignant polyps were classified as “low risk” or “high risk”. The study had two arms: “Intensive follow-up” (42 patients: 32 with low-risk and 10 with high-risk polyps) and “Surgical radicalization” (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the “clinical follow-up” arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers (p < 0.001), mismatches can be explained by high surgical risk or patient’s choice. Only in 5 cases (4.2%), did data analysis not allow to exactly determine the reason for a choice different from protocol criteria. The availability of new risk factors and the evidence of pathological mismatches confirmed the need for future studies on this issue.

Kohsaku Sakaguchi - One of the best experts on this subject based on the ideXlab platform.

Thue Bisgaard - One of the best experts on this subject based on the ideXlab platform.

  • Malignant colorectal polyps: Endoscopic Polypectomy and watchful waiting is not inferior to subsequent bowel resection. A nationwide propensity score-based analysis
    Langenbeck's Archives of Surgery, 2019
    Co-Authors: Katarina Levic, Orhan Bulut, Tine Plato Hansen, Ismail Gogenur, Thue Bisgaard
    Abstract:

    Background and aims The optimal treatment of patients with malignant colorectal polyps is unsettled. The surgical dilemma following Polypectomy is selecting between watchful waiting (WW) and subsequent bowel resection (SBR), but the long-term survival outcomes have not been established yet. This nationwide study compared survival of patients after WW or SBR. Methods Danish nationwide study with 100% follow-up of all patients with malignant colorectal polyps (the Danish Colorectal Cancer Group database) in a 10-year period from 2001 to 2011. All patients’ charts and histological reports were individually reviewed. Survival rates were calculated with Cox proportional hazard model after propensity score matching. Results A total of 692 patients were included (WW, 424 (61.3%), SBR, 268 (38.7%)) with a mean follow-up of 7.5 years (3–188 months). Following propensity score matching, there was no significant difference in overall or disease-free survival ( p  = 0.344 and p  = 0.184) or rate of local recurrence (WW, 7.2%, SBR, 2%, p  = 0.052) or distant metastases (WW, 3.3%, SBR, 4.6%, p  = 0.77). In the SBR group, there was no residual tumor or lymph node metastases in the resected specimen in 82.5% of the patients. Conclusion Subsequent bowel resection may not be superior to Endoscopic Polypectomy and watchful waiting with regard to overall and disease-free survival in patients with malignant colorectal polyps.

  • malignant colorectal polyps Endoscopic Polypectomy and watchful waiting is not inferior to subsequent bowel resection a nationwide propensity score based analysis
    Langenbeck's Archives of Surgery, 2019
    Co-Authors: Katarina Levic, Orhan Bulut, Tine Plato Hansen, Ismail Gogenur, Thue Bisgaard
    Abstract:

    The optimal treatment of patients with malignant colorectal polyps is unsettled. The surgical dilemma following Polypectomy is selecting between watchful waiting (WW) and subsequent bowel resection (SBR), but the long-term survival outcomes have not been established yet. This nationwide study compared survival of patients after WW or SBR. Danish nationwide study with 100% follow-up of all patients with malignant colorectal polyps (the Danish Colorectal Cancer Group database) in a 10-year period from 2001 to 2011. All patients’ charts and histological reports were individually reviewed. Survival rates were calculated with Cox proportional hazard model after propensity score matching. A total of 692 patients were included (WW, 424 (61.3%), SBR, 268 (38.7%)) with a mean follow-up of 7.5 years (3–188 months). Following propensity score matching, there was no significant difference in overall or disease-free survival (p = 0.344 and p = 0.184) or rate of local recurrence (WW, 7.2%, SBR, 2%, p = 0.052) or distant metastases (WW, 3.3%, SBR, 4.6%, p = 0.77). In the SBR group, there was no residual tumor or lymph node metastases in the resected specimen in 82.5% of the patients. Subsequent bowel resection may not be superior to Endoscopic Polypectomy and watchful waiting with regard to overall and disease-free survival in patients with malignant colorectal polyps.