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Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00741676
First received: August 25, 2008
Last updated: December 30, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasm
Procedure: laparoscopy-assisted distal gastrectomy
Procedure: open distal gastrectomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • 2 year survival [ Time Frame: two year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy and clinical out come [ Time Frame: two year ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: August 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Procedure: open distal gastrectomy
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.
Other Name: ODG
Experimental: 1 Procedure: laparoscopy-assisted distal gastrectomy
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.
Other Name: LADG

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741676

Contacts
Contact: Wook Kim, professor 82-32-340-7022 kimwook@catholic.ac.kr
Contact: Wook Kim, Professor 82-32-340-7022 kimwook@catholic.ac.kr

Locations
Korea, Republic of
Department of Surgery, Holy Family Hospital, The Catholic University of Korea Recruiting
Bucheon, Gyunggi Do, Korea, Republic of, 420-717
Contact: Wook Kim, Professor    +82-340-7022    kimwook@catholic.ac.kr   
Contact: Junhyun Lee, Instructor    +82-340-7026    surgeryjun@catholic.ac.kr   
Principal Investigator: Wook Kim, Professor         
Sub-Investigator: Junhyun Lee, Instructor         
Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea Active, not recruiting
Pucheon, Kyunggi-do, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Chair: Wook Kim, Professor Department of Surgery, Holy Family Hospital. The Catholic University of Korea
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institutional review board of Holy Family Hospital.The Catholic University of Korea, Department of Surgery.Holy Family Hospital.
ClinicalTrials.gov Identifier: NCT00741676     History of Changes
Other Study ID Numbers: HFHGS01
Study First Received: August 25, 2008
Last Updated: December 30, 2008
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 27, 2014