Gastric Cancer Clinical Trial
Official title:
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)
Methods National audit of a 90-day prospective observational cohort in which postoperative
complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled
surgery for gastric resection for cancer with or without an intensified recovery program
(ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%)
Research Locations Spanish Hospitals at the state level where these surgical interventions
are performed on a regular basis.
Objectives To determine the incidence of postoperative complications per patient and
procedure, regardless of the degree of adherence to ERAS protocols and its impact on the
hospital stay and postoperative complications including 30-day mortality.
Sample Size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a
number of patients with complications of 28%, the sample size calculation yields 861
patients, although the final sample size it may be smaller depending on the proportion of
complications detected.
Inclusion criteria Patients older than 18 years who are going to undergo surgery for gastric
resection surgery due to cancer regardless of their affiliation to an ERAS intensified
recovery program and the compliance level of the protocol (0-100%)
Statistical analysis Continuous variables will be described as mean and standard deviation,
if it is a normal distribution, or median and interquartile range, if they are not normally
distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the
Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the
factors associated with postoperative complications, hospital stay and death in the hospital.
Univariate analyzes and hierarchical multivariate logistic regression models will be
constructed to identify factors associated independently with these results and to adjust for
differences in confounding factors. The factors will be introduced in the models based on
their relationship with the univariate result (p <0.05), the biological plausibility and the
low rate of missing data.
The results of this study will allow to identify, on the one hand, the type of patients
presenting postoperative complications and, on the other hand, to identify those items of the
ERAS protocols that are independently associated with a reduction in postoperative
complications and hospital stay, which will allow to focus the perioperative efforts in those
items that actually improve the postoperative outcomes.
Aim 1 will establish the number of patients developing predefined postoperative complications
within 30 days of surgery in adult patients undergoing scheduled surgery for gastric
resection for cancer with any compliance of an ERAS protocol (including patients with 0
compliance). This will allow us to determine the actual impact of these protocols.
Aim 2 will allow us to know the type of predefined complication presented by the patients
included in the ERAS protocols and in patients undergoing colorectal surgery; This will
allow, on the one hand, to have a starting point for future clinical trials, and, on the
other hand, to focus efforts to avoid these complications.
Aim 3 will allow us to identify those perioperative items of ERAS protocols that are actually
associated with a decrease in postoperative complications.
The proposed study will establish a real view of the number of patients presenting
postoperative complications that will overcome the limitations of available retrospective
studies and provide greater insight into the items of the protocols that are associated with
decreased complications; on the other hand, the investigator's hypothesis is that the number
of patients who develop predefined postoperative complications within 30 days of surgery
decreases as there is greater compliance with the predefined ERAS protocol items
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03219593 -
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT05536102 -
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT04082364 -
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
|
Phase 2/Phase 3 | |
Withdrawn |
NCT03766607 -
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT01924533 -
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
|
Phase 3 | |
Terminated |
NCT01641939 -
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT04908813 -
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04249739 -
Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
|
Phase 2 | |
Recruiting |
NCT05514158 -
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
|
Phase 1 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 |