Gastric Cancer (GC)
Conditions
Keywords
Gastric Cancer, Neoadjuvant Chemotherapy, Laparoscopic Gastrectomy, Robotic Surgery, Pre-habilitation, Enhanced Recovery After Surgery (ERAS)
Brief summary
This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. The study is a single-center, randomized controlled trial involving patients aged 18-75 years. Participants will be randomly assigned to either a pre-habilitation program plus ERAS or ERAS alone. The primary outcome is the incidence of postoperative complications within 30 days. Secondary outcomes include pathological data, surgical outcomes, patient-reported outcomes, and long-term survival rates.
Detailed description
The study is designed as a prospective, single-center, randomized, open-label, controlled clinical trial to compare the effects of pre-habilitation combined with ERAS versus ERAS alone in patients undergoing laparoscopic (robotic) gastrectomy after neoadjuvant chemotherapy for gastric cancer. The study will enroll patients aged 18-75 years who are scheduled for laparoscopic (robotic) gastrectomy following neoadjuvant chemotherapy. Participants will be randomly assigned in a 1:1 ratio to either the pre-habilitation plus ERAS group or the ERAS group. The pre-habilitation program will include a 4-week intervention involving exercise, nutrition, and psychological support prior to surgery. The primary endpoint is the incidence of postoperative complications within 30 days, assessed using the Clavien-Dindo classification. Secondary endpoints include pathological characteristics, surgical outcomes, patient-reported outcomes, and long-term survival rates. Data will be collected from patient records and follow-up visits. Statistical analysis will be performed using SPSS 26.0 or later versions, with significance level set at α=0.05.
Interventions
BEHAVIORALPre-habilitation Program
A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.
Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age:18-75 years * ECOG:0-2 * ASA:I-III * Histologically confirmed gastric adenocarcinoma (cT3-4aN+M0) * Fit for radical surgery after MDT * Negative pregnancy test within one month * Non-pregnant or non-lactating
Exclusion criteria
* Severe cardiac (LVEF\<30% or NYHA IV) * Severe hepatic or renal dysfunction (Child-Pugh ≥10; CrCl\<25 ml/min) * Recent cerebrovascular events * Concomitant tumors requiring surgery * Emergency surgery for tumor complications, * Severe infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | Postoperative 30-day | The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Intra-operative | Time from skin incision to skin closure. Unit: minutes. |
| Estimated blood loss | Intra-operative | Total volume of intra-operative blood loss. Unit: mL. |
| Pathological ypT stage | At pathology review (within 2 week after surgery) | Tumour infiltration depth in the resection specimen according to AJCC 8th edition. Unit: n (%) - categories T0, T1, T2, T3, T4. |
| Pathological ypN stage | At pathology review (within 2 week after surgery) | Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3. |
| AJCC pathological TNM stage | At pathology review (within 2 week after surgery) | Combined pathological stage. Unit: n (%) - stages I, II, III. |
| Tumour regression grade (TRG) | At pathology review (within 2 week after surgery) | Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3. |
| Time to first flatus | Post-operative period (up to 30 days) | Interval from end of surgery to first rectal gas passage. Unit: days. |
| Time to first liquid diet | Post-operative period (up to 30 days) | Interval from end of surgery to first tolerated liquid intake. Unit: days. |
| Post-operative hospital stay | Post-operative period. | Interval from surgery to hospital discharge. Unit: days. |
| Serum albumin level | Post-operative day 1,3,5. | Serum albumin measured post-operatively. Unit: g/L. |
| Tumour differentiation | At pathology review (within 2 week after surgery) | Histological grade of the tumour. Unit: n (%) - well / moderate / poor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sex distribution | Baseline (day of enrollment) | Biological sex at enrollment Unit: n (%) - Male, Female |
| Height | Baseline (day of enrollment) | Body height measured without shoes Unit: cm |
| Weight | Baseline (day of enrollment) | Body weight measured in light indoor clothing Unit: kg |
| ECOG performance status | Baseline (day of enrollment) | Eastern Cooperative Oncology Group performance score Unit: n (%) - scores 0, 1, 2 |
| Nutritional risk score (NRS 2002) | Baseline (day of enrollment) | Nutritional Risk Screening 2002 total score Unit: n (%) - \<3 vs ≥3 |
| ASA physical status classification | Baseline (day of enrollment) | American Society of Anesthesiologists classification Unit: n (%) - classes 1, 2, 3 |
| Tumor diameter | Baseline (after neoadjuvant therapy, before surgery) | Maximum diameter of the primary tumor on pre-operative imaging Unit: cm |
| Clinical T stage | Baseline (after neoadjuvant therapy, before surgery) | Clinical T category per AJCC 8th edition Unit: n (%) - cT2, cT3, cT4 |
| Clinical N stage | Baseline (after neoadjuvant therapy, before surgery) | Clinical N category per AJCC 8th edition Unit: n (%) - cN0, cN1, cN2, cN3 |
| Six-minute walk test distance | Baseline (after neoadjuvant therapy, before surgery) | Distance walked in 6 minutes on indoor flat track Unit: meters |
| Hospital Anxiety and Depression Scale (HADS) | From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days. | Anxiety and depression symptoms assessed with the 14-item HADS questionnaire; total score 0-21, higher scores indicate greater symptom severity. Unit: score (0-21) |
| Health-related quality of life (EORTC QLQ-C30) | From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days. | Assessed with the 30-item EORTC QLQ-C30 questionnaire; 15 domains (5 functional, 9 symptom/single-item, 1 global QoL). Raw scores are linearly transformed to 0-100 standard scores. Higher functional/global scores = better QoL; higher symptom scores = worse symptoms. Unit: score (0-100) |
Countries
China
Outcome results
None listed