ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer

NCT06489288 | Active Not Recruiting DMC

• 1 other identifier: CLASS12
• Study Type: interventional
• Target: 2,656
• Locations: 1 country
• Sites: 1

Brief Summary

The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.

Conditions

Gastric Cancer; ERAS; Laparoscopic Gastrectomy

Keywords

Gastric Cancer; ERAS; Totally laparoscopic total gastrectomy

Outcome Measures

Primary Outcomes (4)

• QLQ-STO22

  Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery

  Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery

• QLQ-C30 (V3.0)

  Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery

  Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery

• Complication rate

  Complications rate and Clavien-Dindo classification within 1 month after surgery

  1month

• DFS

  Disease-free survival rate at 1 and 3 years after surgery

  1 and 3 years

Study Arms (2)

ERAS group

EXPERIMENTAL

It is necessary to remove the urinary catheter before the patient awakens from anesthesia, drink water orally in the early postoperative period, and remove the drainage tube and nutrition tube in the early postoperative period

Other: ERAS protocol

control group

OTHER

According to conventional treatment measures, there is no need for Enhanced Recovery After Surgery

Other: ERAS protocol

Interventions

ERAS protocol OTHER

The ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu

ERAS group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• ASA I-III;
• ECOG ≤2;
• NRS2002: 0-2;
• Preoperative gastroscopy and pathological biopsy confirmed adenocarcinoma;
• The clinical stage of abdominal hypotonic enhanced CT or ultrasonic gastroscopy is cT2-3N0-3M0 or cT1N+M0 or cT4aN0M0 (according to the AJCC-8thTNM tumor staging);
• Proposed D2 total laparoscopic radical gastrectomy (without limitation on the anastomotic method);
• All patients did not receive adjuvant radiotherapy, chemotherapy, or other cytotoxic treatments before surgery;
• Borrmann I-III ;
• No history of upper abdominal surgery (except for laparoscopic cholecystectomy); no history of peritonitis or pancreatitis
• hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelet ≥100×109/L; ALT, AST≤1 times the upper limit of normal; ALP≤1 times the upper limit of normal; total serum bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥35g/L;

You may not qualify if:

• tumors at the esophagogastric junction or gastric tumors that have invaded the pyloric canal;
• Those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders;
• Severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe drug-dependent arrhythmia, or a history of myocardial infarction within the last 6 months;
• Patients with urinary dysfunction who require long-term indwelling catheters after surgery;
• Patients who need immunosuppressive therapy for organ transplantation;
• Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases;
• Moderate or severe renal impairment \[creatinine clearance equal to or lower than 50ml/min (calculated according to the Cockroft and Gault equation), or serum creatinine \> upper limit of normal (ULN);
• Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction);
• Pregnant or breastfeeding women;
• Previously diagnosed other tumors (excluding cervical cancer and cutaneous melanoma)

Sponsors & Collaborators

• Xijing Hospital: lead
• First Hospital of China Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Tongji Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Gansu Provincial Hospital: collaborator
• Fudan University: collaborator
• Changzhi People's Hospital: collaborator
• Zhejiang University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The Second Affiliated Hospital of Shandong First Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 5, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)