Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301)
NCC052
Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)
1 other identifier
interventional
164
1 country
1
Brief Summary
Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and lesion-lifting gastric wedge resection have been developed for this purpose. However, these methods have the disadvantage of limited indications according to the size, shape and depth of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with lymph node dissection and manual anastomosis with anterior wall lifting method for a patient with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal gastrectomy with lymph node dissections using an automatic stapler instead of manual anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate distance from the lesion to the proximal and distal margins of resection, to perform radical lymph node dissection, and to achieve excellent postoperative recovery. However, there is a very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy and open gastrectomy. A well-designed clinical study to prove the benefit and safety is definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications while maintaining equivalent survival with ODG
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Jun 2003
Longer than P75 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMay 24, 2012
May 1, 2012
2.4 years
October 18, 2007
May 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5 year disease free survival
Laparoscopy assisted distal gastrectomy could be accepted as a oncologically safe and effective treatment if 5 year disease free survival is not inferior compared to open distal gastrectomy. Any recurrence event will be followed up through regular physical and history examinations, imaging by abdominal computed tomography,esophagogastroduodenoscopy and tumor marker like CEA, CA 19-9,and CA 72-4
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Secondary Outcomes (4)
Quality of life measured by EORTC QLQ
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Surgical complications
1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
Postoperative surgical outcome
within 1 week daily
Overall survival
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Study Arms (2)
Laparoscopy assisted distal gastrectomy
EXPERIMENTALLaparoscopy assisted distal gastrectomy with D2 lymph node dissection.Surgery will be done in similar operative extent with control open distal gastrectomy. Omentectomy will be omitted.
Open Distal Gastrectomy
ACTIVE COMPARATORConventional standard D2 open distal gastrectomy without omentectomy.
Interventions
under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.
Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of stomach
- Age: 18-80 years
- Performance status: ECOG 0-1
- Informed consent should be signed
- EGD finding of early gastric cancer
- EUS finding of mucosa and submucosa cancer
- The location of the tumor should be antrum, angle, lower body in greater curvature in UGIS
- No evidence of distant metastasis in abdomen CT, and chest PA
- Regional lymph node metastasis confined to perigastric node (N1) in CT and EUS
You may not qualify if:
- Any comorbidity obviating major surgery
- Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
- Previous upper abdominal operation
- Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration
- Complicated case needed to get emergency operation
- Any accompanying surgical condition needed to be performed in same time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
Related Publications (2)
Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 10.1097/SLA.0b013e318185e62e.
PMID: 18948798RESULTKim YW, Yoon HM, Yun YH, Nam BH, Eom BW, Baik YH, Lee SE, Lee Y, Kim YA, Park JY, Ryu KW. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc. 2013 Nov;27(11):4267-76. doi: 10.1007/s00464-013-3037-x. Epub 2013 Jun 21.
PMID: 23793805DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Woo Kim, M.D., Ph.D.
National Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Gastric Cancer Surgery
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 19, 2007
Study Start
June 1, 2003
Primary Completion
November 1, 2005
Study Completion
December 1, 2010
Last Updated
May 24, 2012
Record last verified: 2012-05