Trial Title:
Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
NCT ID:
NCT00741676
Condition:
Stomach Neoplasm
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopy-assisted distal gastrectomy
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.
Arm group label:
1
Other name:
LADG
Intervention type:
Procedure
Intervention name:
open distal gastrectomy
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.
Arm group label:
2
Other name:
ODG
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Address:
City:
Bucheon
Zip:
420-717
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Wook Kim, Professor
Phone:
+82-340-7022
Email:
kimwook@catholic.ac.kr
Contact backup:
Last name:
Junhyun Lee, Instructor
Phone:
+82-340-7026
Email:
surgeryjun@catholic.ac.kr
Investigator:
Last name:
Wook Kim, Professor
Email:
Principal Investigator
Investigator:
Last name:
Junhyun Lee, Instructor
Email:
Sub-Investigator
Facility:
Name:
Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
Address:
City:
Pucheon
Zip:
420-717
Country:
Korea, Republic of
Status:
Active, not recruiting
Start date:
August 2008
Completion date:
July 2013
Lead sponsor:
Agency:
The Catholic University of Korea
Agency class:
Other
Source:
The Catholic University of Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00741676
