Gastric CancerNCT06365814
ERAS for Gastric Cancer Patients After NACT
An observational study of Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- enhanced recovery after surgery and conventional perioperative management
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.
Who may be able to join
- gastric adenocarcinoma confirmed by histopathology,
- received 2 to 4 cycles of NACT before surgery,
- minimally invasive (DaVinci or laparoscopy) radical gastrectomy with D2 lymph node dissection
Who cannot join
- conversion to open surgery due to intraoperative difficulties or uncontrolled complications (for example, intraoperative massive bleeding),
- inability to complete the planned preoperative chemotherapy,
- infeasibility of performing radical gastrectomy during surgery
- ERAS item implementation rate less than 60%
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
About this study
Official title: Short- and Long-term Outcomes Following Perioperative ERAS Management in Patients Undergoing Minimally Invasive Radical Gastrectomy After Neoadjuvant Chemotherapy: A Single-center Retrospective Propensity Score Matching Cohort Study
Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.
Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed.
Read the detailed description
Patients From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were retrospectively collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.
Perioperative management and follow-up Patients in the conventional group received routine perioperative care, while patients in the ERAS group received the ERAS management protocol. Based on clinical practice, we reconsidered the total clauses in the gastric cancer ERAS pathway and determined that preoperative education, prehabilitation, target-oriented liquid management, preoperative oral carbohydrate intake, multimodal analgesia, minimally invasive surgery, physical activity, individual nutritional evaluation and support were the core terms that are suitable for all patients and should be strictly adhered to. Patients follow-up was strictly in accordance with Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).
NACT and D2 gastrectomy Due to the retrospective design of this study, data from patients who received CapOx, SOX or other 5-fluorouracil-based chemotherapy regimens were collected for analysis. If patients could not complete preoperative chemotherapy as planned due to severe adverse events or if preoperative chemotherapy needed to be prolonged for more than 4 cycles due to unsatisfactory therapeutic efficacy, their data would not be analyzed. If the original regimens were effective before surgery, they were still administered after surgery. If disease progressed after preoperative chemotherapy, subsequent regimens were discussed by a multidisciplinary team. Pre- and postoperative chemotherapy was administered in total of 8 cycles, and this treatment was adjusted according to the patient's disease condition and tolerance.
All patients underwent surgery approximately 4 weeks after the last cycle of preoperative chemotherapy. The extent of gastrectomy was determined according to the tumor location, and the extent of lymph node dissection was strictly in accordance with the D2 standard. The types of digestive tract reconstruction depended on the tumor site, extent of gastric resection, experience and surgeon habits. The choice of laparoscopy or DaVinci-assisted surgery depended on the subjective will of the patients.
Propensity score matching and statistical analysis After excluding patients who did not meet the inclusion criteria, the ERAS group was matched at a ratio of 1:1 with the conventional group including the following covariates: age, PLR, LMR, CAR and prealbumin concentration. SPSS 24.0 was used to perform the match using a 0.2 caliper width.
SPSS 24.0 (IBM, Armonk, NY, USA) was used for the data analysis. The normally distributed measurement data are expressed as mean ± standard deviation (x̅±s); the differences between groups were compared by Student's t test. Measurement data with a nonnormal distribution are presented as medians (interquartile ranges); the Mann-Whitney U test was used for comparisons between two groups. Count data are presented as absolute numbers; comparisons between groups were analyzed using the Chi-square test. The Mann-Whitney U test was used for ranked data. Repeated measures data were analyzed by two-way repeated-measures ANOVA or the generalized estimating equation. Survival curves were plotted using the Kaplan-Meier method, and the differences in survival rate were compared by the log-rank test. Univariate and multivariate analyses of risk factors for RFS and OS were conducted with the Cox proportional hazards regression model. The cutoff values of the continuous variables were determined using the median. The multivariate Cox proportional hazards regression model included variables with p < 0.15 in the univariate analysis. P < 0.05 was considered to indicate statistical significance.
- Conditions
- Gastric Cancer
- Being tested
- enhanced recovery after surgery, conventional perioperative management
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgeryOther
ERAS is a comprehensive perioperative interventions, including preoperative patient education, prehabilitation, nutritional support, minimally invasive surgery and other methods, can reduce surgical stress and promote patient recovery
conventional perioperative managementOther
conventional perioperative management
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Not described Receives: Other: enhanced recovery after surgery | |
| Conventional group | Not described Receives: Other: conventional perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infectious complications
The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.
Measured: up tp 30 days after surgery
Secondary outcomes (4)
postoperative recovery parameter
time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;
Measured: up tp 30 days after surgery
blood test result
CAR (C-reactive protein-albumin ratio), LMR (lymphocyte-to-monocyte ratio), NLR (neutrophil-to-lymphocyte ratio), PLR (platelet-to-lymphocyte ratio), SII (systemic immune-inflammation index), PNI (prognostic nutrition index), prealbumin and albumin on pre- and postoperative day (POD) 1, 3 and 5 were detected dynamically
Measured: Postoperative, on postoperative day 1, 3 and 5
3-year overall survival
Measured: 3 years
3-years recurrence-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhouyanbing, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365814
- Sponsor's protocol ID
- ERASforNACT
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-term Outcomes Following Perioperative ERAS Management in Patients Undergoing Minimally Invasive Radical Gastrectomy After Neoadjuvant Chemotherapy: A Single-center Retrospective Propensity Score Matching Cohort Study
- ClinicalTrials.gov ID
- NCT06365814
- Acronym / sponsor ID
- ERASforNACT
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.
Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed.
Detailed description
Patients From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were retrospectively collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.
Perioperative management and follow-up Patients in the conventional group received routine perioperative care, while patients in the ERAS group received the ERAS management protocol. Based on clinical practice, we reconsidered the total clauses in the gastric cancer ERAS pathway and determined that preoperative education, prehabilitation, target-oriented liquid management, preoperative oral carbohydrate intake, multimodal analgesia, minimally invasive surgery, physical activity, individual nutritional evaluation and support were the core terms that are suitable for all patients and should be strictly adhered to. Patients follow-up was strictly in accordance with Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).
NACT and D2 gastrectomy Due to the retrospective design of this study, data from patients who received CapOx, SOX or other 5-fluorouracil-based chemotherapy regimens were collected for analysis. If patients could not complete preoperative chemotherapy as planned due to severe adverse events or if preoperative chemotherapy needed to be prolonged for more than 4 cycles due to unsatisfactory therapeutic efficacy, their data would not be analyzed. If the original regimens were effective before surgery, they were still administered after surgery. If disease progressed after preoperative chemotherapy, subsequent regimens were discussed by a multidisciplinary team. Pre- and postoperative chemotherapy was administered in total of 8 cycles, and this treatment was adjusted according to the patient's disease condition and tolerance.
All patients underwent surgery approximately 4 weeks after the last cycle of preoperative chemotherapy. The extent of gastrectomy was determined according to the tumor location, and the extent of lymph node dissection was strictly in accordance with the D2 standard. The types of digestive tract reconstruction depended on the tumor site, extent of gastric resection, experience and surgeon habits. The choice of laparoscopy or DaVinci-assisted surgery depended on the subjective will of the patients.
Propensity score matching and statistical analysis After excluding patients who did not meet the inclusion criteria, the ERAS group was matched at a ratio of 1:1 with the conventional group including the following covariates: age, PLR, LMR, CAR and prealbumin concentration. SPSS 24.0 was used to perform the match using a 0.2 caliper width.
SPSS 24.0 (IBM, Armonk, NY, USA) was used for the data analysis. The normally distributed measurement data are expressed as mean ± standard deviation (x̅±s); the differences between groups were compared by Student's t test. Measurement data with a nonnormal distribution are presented as medians (interquartile ranges); the Mann-Whitney U test was used for comparisons between two groups. Count data are presented as absolute numbers; comparisons between groups were analyzed using the Chi-square test. The Mann-Whitney U test was used for ranked data. Repeated measures data were analyzed by two-way repeated-measures ANOVA or the generalized estimating equation. Survival curves were plotted using the Kaplan-Meier method, and the differences in survival rate were compared by the log-rank test. Univariate and multivariate analyses of risk factors for RFS and OS were conducted with the Cox proportional hazards regression model. The cutoff values of the continuous variables were determined using the median. The multivariate Cox proportional hazards regression model included variables with p < 0.15 in the univariate analysis. P < 0.05 was considered to indicate statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Other: enhanced recovery after surgery |
| Conventional group | – | Other: conventional perioperative management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.
Key inclusion criteria (3 listed)
- gastric adenocarcinoma confirmed by histopathology,
- received 2 to 4 cycles of NACT before surgery,
- minimally invasive (DaVinci or laparoscopy) radical gastrectomy with D2 lymph node dissection
Key exclusion criteria (4 listed)
- conversion to open surgery due to intraoperative difficulties or uncontrolled complications (for example, intraoperative massive bleeding),
- inability to complete the planned preoperative chemotherapy,
- infeasibility of performing radical gastrectomy during surgery
- ERAS item implementation rate less than 60%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced recovery after surgeryERAS is a comprehensive perioperative interventions, including preoperative patient education, prehabilitation, nutritional support, minimally invasive surgery and other methods, can reduce surgical stress and promote patient recovery | Other | ERAS group |
| conventional perioperative managementconventional perioperative management | Other | Conventional group |
Primary outcome
postoperative infectious complications
Time frame: up tp 30 days after surgery
The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.
4 secondary outcomes
postoperative recovery parameter
Time frame: up tp 30 days after surgery
blood test result
Time frame: Postoperative, on postoperative day 1, 3 and 5
3-year overall survival
Time frame: 3 years
3-years recurrence-free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative infectious complications (time frame: up tp 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.