Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients
NCT ID: NCT03564834
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2018-08-23
2023-07-30
Brief Summary
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Detailed Description
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Laparoscopic gastrectomy is one of the standard treatments for early gastric cancer and has demonstrated its application value in local advanced gastric cancer. Two recent meta-analysis on observational studies have shown the feasibility of laparoscopic gastrectomy in elderly gastric cancer patients. Compared to conventional open resections, elderly patients may benefit from the advantages of laparoscopic approach such as less trauma, less blood loss, faster bowel movement recovery, earlier food intake, and shorter hospitalization. However, laparoscopic gastrectomy raises issues such as prolonged operation time and disturbance of circulatory and respiratory dynamics by carbon dioxide pneumoperitoneum during the procedure. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias and evidence on long-term survival is scarce. The investigators therefore proposed to conduct this randomized controlled trial comparing the feasibility and survival benefit of laparoscopic with open gastrectomy for elderly patients with local advanced gastric cancer. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic gastrectomy
A standard laparoscopic gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).
Laparoscopic gastrectomy
Patients will receive laparoscopic gastrectomy within one week after randomization.
Open gastrectomy
A standard open gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).
Open gastrectomy
Patients will receive open gastrectomy within one week after randomization.
Interventions
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Laparoscopic gastrectomy
Patients will receive laparoscopic gastrectomy within one week after randomization.
Open gastrectomy
Patients will receive open gastrectomy within one week after randomization.
Eligibility Criteria
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Inclusion Criteria
* Karnofsky score≥70%
* Histologically proven gastric adenocarcinoma in biopsy (including Lauren classification) Proven clinical stage of cT2-4aNanyM0 by baseline ultrasound endoscope, enhanced CT/MRI examination, or diagnostic laparoscopy using Habermann Standards
* No past chemotherapy or radiotherapy before diagnosis
* Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) via distal subtotal or total gastrectomy plus lymphadenectomy
* Haematology and biochemistry index meet the following: hemoglobin≥80g/L, absolute neutrophils count (ANC)≥1.5×109/L, platelet≥100×109/L, ALT、AST≤2.5 times the upper limit of normal value, ALP≤2.5 times the upper limit of normal value, serum total bilirubin\<1.5 times the upper limit of normal value, serum creatinine\<1 times the upper limit of normal value, serum albumin≥30g/L
* Heart and lung function can withstand surgery
* No severe concomitant disease that leads to survival\<3 years
* Willing and able to comply with study protocol Written agreement consent before enrolment and full aware of the right to quit the study at any time with no loss
Exclusion Criteria
* Past history of upper abdominal surgery (except for laparoscopic cholecystectomy)
* Past history of gastric surgery (including diagnosis procedure such as ESD and EMR)
* Other malignant diseases in 5 years (except for cured skin carcinoma and cervical carcinoma in situ)
* Clinical severe or active heart diseases, such as symptomatic coronary heart disease, NYHA grade II or above congestive heart failure, severe arrhythmia, or myocardial infarction in 6 months
* Cerebral hemorrhage or infarction in 6 months
* Organ transplant recipients under immunosuppressive therapy
* Severe uncontrolled repeated infection or other severe uncontrolled concomitant diseases
* Medium or severe renal damage (creatinine clearance rate≤50ml/min or serum creatinine\> upper limit of normal value)
* Other diseases requiring synchronous surgery
* Requiring emergent surgery due to oncologic emergent (e.g. bleeding, perforation, obstruction)
* FEV1\<50% of expected value Participated in other studies 4 weeks before the randomization.
70 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Ziyu Li, MD
Deputy Director of Department of Surgery
Principal Investigators
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Ziyu Li, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital and Institute
Locations
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Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Li Z, Shan F, Ying X, Xue K, Ji J. Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial. BMC Cancer. 2018 Nov 16;18(1):1118. doi: 10.1186/s12885-018-5041-y.
Other Identifiers
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SF2018-4-2156
Identifier Type: -
Identifier Source: org_study_id
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