Clinical trial NCT00741676: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stomach Neoplasm
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 2 year survival
timeFrame: two year
Secondary outcomes:
measure: efficacy and clinical out come
timeFrame: two year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Department of Surgery, Holy Family Hospital, The Catholic University of Korea
state: Gyunggi Do
city: Pucheon
country: Korea, Republic of
facility: Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
state: Kyunggi-do
Study officials:
affiliation: Department of Surgery, Holy Family Hospital. The Catholic University of Korea
name: Wook Kim, Professor
role: STUDY_CHAIR
References:
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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.
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.
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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.
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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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.
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citation: Song KY, Kim SN, Park CH. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer: technical and oncologic aspects. Surg Endosc. 2008 Mar;22(3):655-9. doi: 10.1007/s00464-007-9431-5.
citation: Kim MC, Kim KH, Kim HH, Jung GJ. Comparison of laparoscopy-assisted by conventional open distal gastrectomy and extraperigastric lymph node dissection in early gastric cancer. J Surg Oncol. 2005 Jul 1;91(1):90-4. doi: 10.1002/jso.20271.
citation: Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
citation: Lee J, Kim W. Long-term outcomes after laparoscopy-assisted gastrectomy for advanced gastric cancer: analysis of consecutive 106 experiences. J Surg Oncol. 2009 Dec 15;100(8):693-8. doi: 10.1002/jso.21400.