Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasm
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
laparoscopy-assisted distal gastrectomy
open distal gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: older than 20 year old, younger than 80 year old
- Cancer core: located at the middle or lower part of stomach
- Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Exclusion Criteria:
- Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
- Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
- Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
- Patient who was treated because of systemic inflammatory disease
- Pregnant patient
- Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
Sites / Locations
- Department of Surgery, Holy Family Hospital, The Catholic University of KoreaRecruiting
- Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
Outcomes
Primary Outcome Measures
2 year survival
Secondary Outcome Measures
efficacy and clinical out come
Full Information
NCT ID
NCT00741676
First Posted
August 25, 2008
Last Updated
December 30, 2008
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT00741676
Brief Title
Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
Official Title
Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery. Complications such as pain, abdominal adhesion, and problems associated with delayed recovery are common in open surgery because of large incision; however, those complications are less common in laparoscopy surgery because small sized incision is prepared. Range of surgery for curative dissection depends on the level of progress of a cancer, i.e., depends on whether gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since recurrence in the lymph nodes after the operation is very common, the most important step in the gastric surgery is to dissect lymph node completely. According to the gastric cancer surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node dissection is essential for improving survival rate in advanced gastric cancer. More than D2 lymph node dissection is relatively safely conducted by open surgery, whereas it is controversial in laparoscopy surgery because it is very hard to maintain surgical field under laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy is possible as laparoscopic surgical techniques are accumulated and new surgical devices are introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery shows similar results to the one by open surgery in aspects of recurrence rate and the number of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer, laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case study, the investigators would like to compare effectiveness, complications, patterns of recurrence, and survival rate between the two surgical approaches, laparoscopy distal gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the investigators wish our case report to contribute to the establishment of the safety and the effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently, our case report will contribute to establish the ideal surgical method for the advanced gastric cancer patients.
Detailed Description
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth II method will be used for gastric reconstruction for all cases.Billroth II gastrectomy is to link the gastric pouch to the jejunum 10~15 cm distal to the ligament of Treitz. An antecolic or retrocolic gastrojejunostomy connects the jejunum to the stomach in one continuous segment. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
laparoscopy-assisted distal gastrectomy
Other Intervention Name(s)
LADG
Intervention Description
10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3~5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed.
Intervention Type
Procedure
Intervention Name(s)
open distal gastrectomy
Other Intervention Name(s)
ODG
Intervention Description
Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.
Primary Outcome Measure Information:
Title
2 year survival
Time Frame
two year
Secondary Outcome Measure Information:
Title
efficacy and clinical out come
Time Frame
two year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
Age: older than 20 year old, younger than 80 year old
Cancer core: located at the middle or lower part of stomach
Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
ASA score: ≤ 3
Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Exclusion Criteria:
Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
Patient who was treated because of systemic inflammatory disease
Pregnant patient
Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wook Kim, professor
Phone
82-32-340-7022
Email
kimwook@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wook Kim, Professor
Organizational Affiliation
Department of Surgery, Holy Family Hospital. The Catholic University of Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
City
Bucheon
State/Province
Gyunggi Do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wook Kim, Professor
Phone
+82-340-7022
Email
kimwook@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Junhyun Lee, Instructor
Phone
+82-340-7026
Email
surgeryjun@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Wook Kim, Professor
First Name & Middle Initial & Last Name & Degree
Junhyun Lee, Instructor
Facility Name
Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
City
Pucheon
State/Province
Kyunggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
11706767
Citation
Yano H, Monden T, Kinuta M, Nakano Y, Tono T, Matsui S, Iwazawa T, Kanoh T, Katsushima S. The usefulness of laparoscopy-assisted distal gastrectomy in comparison with that of open distal gastrectomy for early gastric cancer. Gastric Cancer. 2001;4(2):93-7. doi: 10.1007/pl00011730.
Results Reference
background
PubMed Identifier
15746786
Citation
Mochiki E, Kamiyama Y, Aihara R, Nakabayashi T, Asao T, Kuwano H. Laparoscopic assisted distal gastrectomy for early gastric cancer: Five years' experience. Surgery. 2005 Mar;137(3):317-22. doi: 10.1016/j.surg.2004.10.012.
Results Reference
background
PubMed Identifier
9610656
Citation
Morita M, Baba H, Fukuda T, Taketomi A, Kohnoe S, Seo Y, Saito T, Tomoda H, Sugimachi K. Submucosal gastric cancer with lymph node metastasis. J Surg Oncol. 1998 May;68(1):5-10. doi: 10.1002/(sici)1096-9098(199805)68:13.0.co;2-b.
Results Reference
background
PubMed Identifier
12021853
Citation
Nakajima T. Gastric cancer treatment guidelines in Japan. Gastric Cancer. 2002;5(1):1-5. doi: 10.1007/s101200200000.
Results Reference
background
PubMed Identifier
16247578
Citation
Noshiro H, Nagai E, Shimizu S, Uchiyama A, Tanaka M. Laparoscopically assisted distal gastrectomy with standard radical lymph node dissection for gastric cancer. Surg Endosc. 2005 Dec;19(12):1592-6. doi: 10.1007/s00464-005-0175-9. Epub 2005 Oct 24.
Results Reference
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PubMed Identifier
17705092
Citation
Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
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PubMed Identifier
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Citation
Huscher CG, Mingoli A, Sgarzini G, Brachini G, Binda B, Di Paola M, Ponzano C. Totally laparoscopic total and subtotal gastrectomy with extended lymph node dissection for early and advanced gastric cancer: early and long-term results of a 100-patient series. Am J Surg. 2007 Dec;194(6):839-44; discussion 844. doi: 10.1016/j.amjsurg.2007.08.037.
Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
derived
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Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
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