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Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study (RevRadPAC)
| Condition or disease | Intervention/treatment |
|---|---|
| Pancreatic Ductal Adenocarcinoma | Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review) |
Since 2012 in Reggio Emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic PDACs and radiological review of CT scans by an experienced radiologist.
The aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. The investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral.
Through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic PDAC by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. Since 2012 was the transitional year when the protocol was introduced, patients diagnosed with PDAC in 2012 were excluded.
| Study Type : | Observational |
| Actual Enrollment : | 316 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC) |
| Actual Study Start Date : | June 15, 2018 |
| Actual Primary Completion Date : | July 15, 2018 |
| Actual Study Completion Date : | January 15, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
| PDAC patients diagnosed in 2008-2011 | |
| PDAC patients diagnosed in 2013-2016 |
Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)
Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.
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- Proportion of surgical failures on the total of eligible patients [ Time Frame: immediately after surgery ]proportion of patients with incomplete resection or who received surgery in which resection was not possible
- Overall survival [ Time Frame: 24 months ]overall survival (restricted to patients with at least 24 months follow-up)
- proportion of patients referred to different therapeutic options [ Time Frame: up to 1 year ]proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery)
| Ages Eligible for Study: | up to 85 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods
Exclusion Criteria:
- pancreatic cancers with cytohistological diagnosis different from PDAC,
- diagnosis in 2012,
- metastatic disease at diagnosis (stage IV) or unknown stage at diagnosis,
- patients aged >85 years.
| Italy | |
| Azienda USL - IRCCS di Reggio Emilia | |
| Reggio Emilia, Italy, 42123 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||
| First Posted Date | June 4, 2019 | ||||
| Last Update Posted Date | June 4, 2019 | ||||
| Actual Study Start Date | June 15, 2018 | ||||
| Actual Primary Completion Date | July 15, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Proportion of surgical failures on the total of eligible patients [ Time Frame: immediately after surgery ] proportion of patients with incomplete resection or who received surgery in which resection was not possible
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study | ||||
| Official Title | Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC) | ||||
| Brief Summary | The investigators compared two different time periods respectively before and after the application of a dedicated diagnostic and therapeutic protocol for pancreatic ductal adenocarcinoma including multidisciplinary discussion and radiological review of cases, in order to evaluate the impact of the new protocol on surgical failures and overall survival. | ||||
| Detailed Description |
Since 2012 in Reggio Emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic PDACs and radiological review of CT scans by an experienced radiologist. The aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. The investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral. Through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic PDAC by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. Since 2012 was the transitional year when the protocol was introduced, patients diagnosed with PDAC in 2012 were excluded. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The Reggio Emilia Pancreatic Cancer Register registered 1157 PDAC cases from 2008 to 2016. After exclusion of cases diagnosed in 2012, patients aged >85 years and cancer staged as IV or with unknown stage, a total of 132 and 184 patients were included in analysis respectively for 2008-2011 and 2013-2016 periods. | ||||
| Condition | Pancreatic Ductal Adenocarcinoma | ||||
| Intervention | Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)
Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
316 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 15, 2019 | ||||
| Actual Primary Completion Date | July 15, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 85 Years (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03973736 | ||||
| Other Study ID Numbers | 286/2018/OSS/AUSLRE | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Azienda Unità Sanitaria Locale Reggio Emilia | ||||
| Study Sponsor | Azienda Unità Sanitaria Locale Reggio Emilia | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Azienda Unità Sanitaria Locale Reggio Emilia | ||||
| Verification Date | June 2019 | ||||
