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Trial Title:
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
NCT ID:
NCT05541783
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric cancer，Laparoscopic distal gastrectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopy-assisted distal gastrectomy Group
Description:
LADG
Arm group label:
Laparoscopy-assisted distal gastrectomy
Intervention type:
Procedure
Intervention name:
Totally laparoscopic distal gastrectomy
Description:
TLDG
Arm group label:
Totally laparoscopic distal gastrectomy
Summary:
The aim of this study is comparing the short-term quality of life between
laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for
gastric cancer.
Detailed description:
Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal
gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same
surgical treatment principles, in the former, all surgical processes are performed
intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is
achieved. Whether the procedural differences between TLDG and LADG affect quality of life
（QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of
patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring
by questionnaire) between the patients undergoing TLDG and LADG through a multi-center
randomized controlled trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal
Joint Committee on Cancer System (Clinical stage was determined based on the finding
of gastrofiberscopy and abdominal computed tomography)
- scheduled for laparoscopic distal gastrectomy with D2 lymphadenectomy, and possible
for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the
criteria of the Japanese
- written informed consent
- tumor size<5cm preoperatively
Exclusion Criteria:
- clinical stage T1-4N0-3M1 according to the 8th edition of the Americal Joint
Committee on Cancer System
- history of chemotherapy, radiotherapy, immunotherapy or target therapy
- perigastric lymphnode≥3cm
- received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- multiple primary tumors
- suffering from other serious diseases, including cardiovascular, respiratory,
kidney, or liver disease, complicated by poorly controlled hypertension, diabetes,
mental disorders or diseases.
- patients need emergency operation with complication of gastric cancer
- adhesion due to the previous intraabdominal surgery
- need for combined organ resection due to aggression of gastric cancer of other
disease,
- vulnerable people who cannot communicate or are pregnant (or planning to be
pregnant)
- currently participating or participated in other clinical trials in the last 6
months
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Dazhi Xu, PHD，MD
Phone:
021-64175590
Email:
xudzh@shca.org.cn
Start date:
September 15, 2022
Completion date:
September 15, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541783
