- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286984
Implementation of a Patient Blood Management Program in Gastric Cancer Surgery (IPAT)
Study of the Efficacy of a Patient Blood Management Program Implemented in Patients Undergoing Curative Gastric Cancer Resection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Spanish EURopEan CanCer Audit (EURECCA) Esophagogastric Cancer Group is a surgical quality improvement project, linked to the EURECCA network in Europe. EURECCA's population-based registry prospectively collects clinical data from all public hospitals in the participating regions providing them with their outcomes benchmarked against other hospitals. Ninety variables with detailed definitions are prospectively collected from each patient by the reference surgeon at each institution. Validation of completeness and accuracy of data registration (period 2014-2017) has recently been performed revealing a completeness rate of 97% and an accuracy rate of 95% (ClinicalTrials.gov, NCT03541629, pending publication).
During a workshop of the Spanish EURECCA Esophagogastric Cancer Group in May 2014, a wide heterogeneity in perioperative transfusion policies among hospitals was detected. After several meetings, a unified protocol of PBM measures (upPBM) was agreed in February 2016. Briefly, the upPBM included strategies to address two PBM pillars: anemia detection and treatment according to the algorithm described in Figure 1; and a restrictive transfusion practice according to national guidelines for transfusion triggers. After performing a laboratory work-up 2 to 4 weeks before surgery, preoperative iron supplementation in case of iron deficiency anemia at least 7 days before surgery was recommended. Preoperative anemia was defined by a Hb level < 13 g/dL for both sexes. In anemic patients, iron status study was recommended and iron supplementation with intravenous iron was indicated if Hb<12g/dL and/or ferritin <300 mg/l. Intravenous iron (ferric sucrose or carboxymaltose) was administrated with the goal of recovering iron deficit, calculated using the Ganzoni formula or by the simplified strategy, only available for ferric carboxymaltose. Recommended transfusion triggers were: Hb < 9 g/dL for patients with risk factors and/or anemia symptoms; and Hb < 7 g/dL for the rest of patients in absence of active bleeding.
After consensus, the upPBM was introduced through specific workshops to the members of the local multidisciplinary team from all participating hospitals by the two principal investigators of this study, and approval was obtained from each Institutional Review Board. Start of application of upPBM was prospectively communicated to the principal investigator of the study by the reference surgeon in each center.
The aim of this study is to evaluate the implementation and efficacy of a PBM protocol on perioperative RBCT and postoperative outcomes for patients undergoing gastric cancer resection with curative intent.
This is a multicenter retrospective study on a prospective cohort of consecutive patients undergoing elective gastric cancer resection with curative intent between January 2014 and December 2018 in hospitals of the Spanish EURECCA project which implemented the upPBM before December 31th, 2017, to ensure a minimum 1-year follow-up. Patients are divided in 2 groups: those with a diagnosis of gastric cancer before the upPBM implementation in their attending center and those with a diagnosis afterwards.
Recorded data for each patient are age, sex, American Society of Anesthesiologists Classification (ASA class), Body Mass Index (BMI), percentage of unintended weight loss 6 months before surgery, Charlson Comorbidity Index (CCI) (categorized as 0, 1-2, and > 3), tumor location, tumoral pathological stage (8th edition, Union for International Cancer Control, UICC), neoadjuvant treatment, type of gastrectomy (distal subtotal or total), extension of lymphadenectomy according to the Japanese Gastric Cancer Association Classification (D), surgical approach (open or minimally invasive), associated multivisceral resection, Hb at diagnosis and before surgery, preoperative intravenous iron treatment, number of transfused units, moment of transfusion (pre- or perioperative), postoperative complications, hospital readmission and mortality. Transfusion Rate (TR) is defined as the percentage of patients receiving any RBCT over the total of patients. Transfusion Index (TI) is defined as the total number of RBC units transfused divided by the number of transfused patients. Both TR and TI are defined as preoperative (from the date of diagnosis of gastric cancer to the date of surgery), perioperative (from the date of surgery to the date of hospital discharge) or global (from the date of diagnosis to the date of hospital discharge). Postoperative complications were recorded the 30 first days after surgery, defined according to the Gastrectomy Complications Consensus Group (GCCG) and graded with the Clavien-Dindo (CD) classification. Readmissions are considered during the 30 first days after hospital discharge and mortality is recorded during the 90 first days after surgery. Failure-to-rescue was calculated as the proportion of patients with a severe complication (Clavien-Dindo score >IIIa) dying during the first 90 days after surgery.
Primary endpoints are global, preoperative and perioperative TR. Secondary endpoints were TI, Hb improvement after preoperative treatment with intravenous iron, overall, severe and infectious postoperative complications rates, length of stay, and mortality. Protocol compliance is evaluated with the following measures: determination of Hb > 14 days before surgery; determination of ferritin in patients with Hb < 13 g/dL; percentage of patients with Hb <12 g/dL and/or ferritin < 300 mg/l at diagnosis treated preoperatively with intravenous iron > 7 days before surgery; and percentage of patients transfused following upPBM threshold recommendations.
Data variables are described using counts and percentages, means and standard deviation or median and interquartile range (IQR) as needed. For basal patient, tumor and surgery characteristics, comparation before and after upPBM is done with a Chi2 study for discontinuous and t Student study for continuous variables, considering significant difference when p<0.05. For study outcomes, raw and adjusted differences before and after upPBM implementation are reported with a 95% confidence interval (CI95%).Variables used in the adjustment are possible confounding factors that, based on the investigator's previous experience and published data, could vary during the study period and have a potential impact on perioperative transfusion, postoperative morbidity and length of stay: age, CCI score, neoadjuvant treatment, type of gastrectomy (subtotal or total), minimally invasive surgery, lymphadenectomy extension (D), and visceral associated resection. To assess global, preoperative and intra + postoperative TR difference before and after upPBM implementation a zero-inflated negative binomial regression model is used. To assess postoperative complications, reoperation, hospital readmission (30 days) and postoperative mortality (90 days) difference before and after upPBM implementation a logistic regression model is used. Estimates are bounded by 95% confidence intervals. Statistical significance was held at 5%. All analyses are performed using R version 3.6.1.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing elective gastric cancer resection with curative intent between January 2014 and December 2018 in hospitals of the Spanish EURECCA project which implemented the upPBM before December 31th, 2017.
Exclusion Criteria:
- Metastasis
- Palliative Surgery
- Hospitals non implementing the upPBM before December 31th, 2017
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-upPBM
Patients with a diagnosis of gastric cancer before the upPBM implementation in their attending center
|
|
Post-upPBM
Patients with a diagnosis of gastric cancer after the upPBM implementation in their attending center
|
upPBM description: After performing a laboratory work-up 2 to 4 weeks before surgery, preoperative iron supplementation in case of iron deficiency anemia at least 7 days before surgery was recommended.
Preoperative anemia was defined by a Hb level < 13 g/dL for both sexes.
In anemic patients, iron status study was recommended and iron supplementation with intravenous iron was indicated if Hb<12g/dL and/or ferritin <300 mg/l.
Intravenous iron (ferric sucrose or carboxymaltose) was administrated with the goal of recovering iron deficit, calculated using the Ganzoni formula or by the simplified strategy, only available for ferric carboxymaltose.
Recommended transfusion triggers were: Hb < 9 g/dL for patients with risk factors and/or anemia symptoms; and Hb < 7 g/dL for the rest of patients in absence of active bleeding.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfusion Rate
Time Frame: 2014-2018
|
Percentage of patients receiving any red blood cell trasfusion over the total of patients
|
2014-2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfusion Index
Time Frame: 2014-2018
|
Total number of red blood cell units transfused divided by the number of transfused patients
|
2014-2018
|
Rate of postoperative complications
Time Frame: 2014-2018
|
Postoperative complications recorded the 30 first days after surgery, defined according to the Gastrectomy Complications Consensus Group (GCCG) and graded with the Clavien-Dindo (CD) classification
|
2014-2018
|
Readmission rate
Time Frame: 2014-2018
|
Hospital readmissions during the 30 first days after hospital discharge
|
2014-2018
|
Length of stay
Time Frame: 2014-2018
|
Postoperative stay from surgery to hospital discharge
|
2014-2018
|
Mortality rate
Time Frame: 2014-2018
|
Mortality recorded during the 90 first days after surgery
|
2014-2018
|
Percentage of failure-to-rescue
Time Frame: 2014-2018
|
Proportion of patients with a severe complication (Clavien-Dindo score >IIIa) dying during the first 90 days after surgery
|
2014-2018
|
Collaborators and Investigators
Investigators
- Principal Investigator: Javier Osorio, MD, PhD, Hospital Universitari de Bellvitge
Publications and helpful links
General Publications
- Messager M, de Steur WO, van Sandick JW, Reynolds J, Pera M, Mariette C, Hardwick RH, Bastiaannet E, Boelens PG, van deVelde CJ, Allum WH; EURECCA Upper GI Group. Variations among 5 European countries for curative treatment of resectable oesophageal and gastric cancer: A survey from the EURECCA Upper GI Group (EUropean REgistration of Cancer CAre). Eur J Surg Oncol. 2016 Jan;42(1):116-22. doi: 10.1016/j.ejso.2015.09.017. Epub 2015 Sep 30.
- Messager M, de Steur W, Boelens PG, Jensen LS, Mariette C, Reynolds JV, Osorio J, Pera M, Johansson J, Kolodziejczyk P, Roviello F, De Manzoni G, Monig SP, Allum WH; EURECCA Upper GI group (European Registration of Cancer Care). Description and analysis of clinical pathways for oesophago-gastric adenocarcinoma, in 10 European countries (the EURECCA upper gastro intestinal group - European Registration of Cancer Care). Eur J Surg Oncol. 2016 Sep;42(9):1432-47. doi: 10.1016/j.ejso.2016.01.001. Epub 2016 Feb 6.
- Allum W, Osorio J. EURECCA oesophago-gastric cancer project. Cir Esp. 2016 May;94(5):255-6. doi: 10.1016/j.ciresp.2015.12.005. Epub 2016 Mar 2. No abstract available. English, Spanish.
- Jerico C, Osorio J, Garcia-Erce JA, Pera M. Patient Blood Management strategies for iron deficiency anemia management in gastric cancer. Eur J Gastroenterol Hepatol. 2019 Apr;31(4):547-548. doi: 10.1097/MEG.0000000000001383. No abstract available.
- Osorio J, Jerico C, Miranda C, Garsot E, Luna A, Miro M, Santamaria M, Artigau E, Rodriguez-Santiago J, Castro S, Feliu J, Aldeano A, Olona C, Momblan D, Ruiz D, Galofre G, Pros I, Garcia-Albeniz X, Lozano M, Pera M. Perioperative transfusion management in gastric cancer surgery: Analysis of the Spanish subset of the EURECCA oesophago-gastric cancer registry. Cir Esp (Engl Ed). 2018 Nov;96(9):546-554. doi: 10.1016/j.ciresp.2018.03.010. English, Spanish.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPAT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Cancer
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
Clinical Trials on unified protocol of Patient Blood Management measure
-
Duke UniversityCompletedMisophoniaUnited States
-
Fundació Sant Joan de DéuParc Sanitari Sant Joan de DéuRecruitingPsychosis | Emotional DysfunctionSpain
-
Boston University Charles River CampusCompletedAnxiety Disorders | Emotional Disorders
-
Instituto de Investigación Sanitaria AragónRecruitingDepressive Disorder | Anxiety Disorders | Emotional Disorder | Post COVID-19 ConditionSpain
-
Jorge Javier Osma LópezUniversidad de Zaragoza; Instituto de Salud Carlos IIINot yet recruiting
-
University of PittsburghCompletedDepression | Anxiety | Posttraumatic Stress Disorder | Alcohol Use DisorderUnited States
-
Palo Alto UniversitySuspended
-
Rush University Medical CenterCompletedSmoking Cessation | Tobacco Use | Copd | Nicotine Dependence | Cigarette SmokingUnited States
-
University of Los Andes, ColumbiaCompletedEmotional DisorderColombia
-
University of MiamiThe Children's Trust, Miami FLRecruitingDepressive Disorder | Parenting | Anxiety Disorder | Mental Health IssueUnited States