Prehabilitation Plus ERAS in Gastric Cancer Surgery

NCT07328633 | Completed

• 1 other identifier: QYFYEC2025-08
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer (GC)

Keywords

Gastric Cancer; Neoadjuvant Chemotherapy; Laparoscopic Gastrectomy; Robotic Surgery; Pre-habilitation; Enhanced Recovery After Surgery (ERAS)

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Complications

  The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).

  Postoperative 30-day

Secondary Outcomes (11)

• Operation time

  Intra-operative

• Estimated blood loss

  Intra-operative

• Pathological ypT stage

  At pathology review (within 2 week after surgery)

• Pathological ypN stage

  At pathology review (within 2 week after surgery)

• AJCC pathological TNM stage

  At pathology review (within 2 week after surgery)

Other Outcomes (12)

• Sex distribution

  Baseline (day of enrollment)

• Height

  Baseline (day of enrollment)

• Weight

  Baseline (day of enrollment)

Study Arms (2)

Pre-habilitation + ERAS

EXPERIMENTAL

Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.

Behavioral: Pre-habilitation Program; Procedure: Enhanced Recovery After Surgery (ERAS) Protocol

ERAS Only

ACTIVE COMPARATOR

Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.

Procedure: Enhanced Recovery After Surgery (ERAS) Protocol

Interventions

Enhanced Recovery After Surgery (ERAS) Protocol PROCEDURE

Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

ERAS Only; Pre-habilitation + ERAS

Pre-habilitation Program BEHAVIORAL

A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.

Pre-habilitation + ERAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Related Publications (5)

• Ajani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR, Sundar H; National Comprehensive Cancer Network. Gastric cancer, version 2.2013: featured updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2013 May 1;11(5):531-46. doi: 10.6004/jnccn.2013.0070.

  PMID: 23667204 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

• Xing J, Wang Y, Shan F, Li S, Jia Y, Ying X, Zhang Y, Li Z, Ji J. Comparison of totally laparoscopic and laparoscopic assisted gastrectomy after neoadjuvant chemotherapy in locally advanced gastric cancer. Eur J Surg Oncol. 2021 Aug;47(8):2023-2030. doi: 10.1016/j.ejso.2021.02.002. Epub 2021 Feb 6.

  PMID: 33663942 RESULT

• Zhong H, Liu X, Tian Y, Cao S, Li Z, Liu G, Sun Y, Zhang X, Han Z, Meng C, Jia Z, Wang Q, Zhou Y. Comparison of short- and long-term outcomes between laparoscopic and open gastrectomy for locally advanced gastric cancer following neoadjuvant chemotherapy: a propensity score matching analysis. Surg Endosc. 2023 Aug;37(8):5902-5915. doi: 10.1007/s00464-023-10052-7. Epub 2023 Apr 18.

  PMID: 37072637 RESULT

• Liu G, Cao S, Liu X, Tian Y, Li Z, Sun Y, Zhong H, Wang K, Zhou Y. 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 study. Eur J Surg Oncol. 2025 Jan;51(1):109459. doi: 10.1016/j.ejso.2024.109459. Epub 2024 Nov 15.

  PMID: 39566200 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Enhanced Recovery After Surgery; Clinical Protocols

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: January 9, 2026
• Study Start: December 5, 2024
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start date:Main results publication date. End date:5 years after publication.
• Access Criteria: Data will be available to qualified researchers upon reasonable request. Requests should be sent to 17866805578@163.com with a brief research proposal. A data-sharing agreement is required. Data will be provided in CSV format within 3 months of request approval.

Locations

CN (1)