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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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 groups in NCT06365814
Study groupRoleWhat they receive
ERAS groupNot described
Receives: Other: enhanced recovery after surgery
Conventional groupNot described
Receives: Other: conventional perioperative management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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. 3-year overall survival

    Measured: 3 years

  4. 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.

  1. First posted15 Apr 2024
  2. Study start1 Oct 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

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)
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

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.

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