Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: laparoscopy-assisted distal gastrectomy Group
* Procedure: Totally laparoscopic distal gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopy-assisted distal gastrectomy<br>The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction. | Procedure: laparoscopy-assisted distal gastrectomy Group<br>* LADG<br>|
| Experimental: Totally laparoscopic distal gastrectomy<br>The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy. | Procedure: Totally laparoscopic distal gastrectomy<br>* TLDG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire | Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative | 1 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the other scales of EORTC QLQ-C30 questionnaire postoperative | Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative | 1 months postoperative | 
| Scores on EORTC QLQ-C30 questionnaire | Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative | 7 day and 1 months postoperative | 
| Usage of analgesics | Usage of analgesics postoperatively | 1-7 day postoperative | 
| Length of stay | Length of stay | 1 months postoperative | 
| Scores on the other scales of ST22 questionnaire postoperative | Scores on the other scales of ST22 questionnaire at 1 months postoperative | 1 months postoperative | 
| Scores on ST22 questionnaire | Scores on ST22 questionnaire at 7 day and 1 months postoperative | 7 day and 1 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer，Laparoscopic distal gastrectomy