Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
30 de diciembre de 2008 actualizado por: The Catholic University of Korea
Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
124
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Gyunggi Do
-
Bucheon, Gyunggi Do, Corea, república de, 420-717
- Reclutamiento
- Department of Surgery, Holy Family Hospital, The Catholic University of Korea
-
Investigador principal:
- Wook Kim, Professor
-
Sub-Investigador:
- Junhyun Lee, Instructor
-
Contacto:
- Wook Kim, Professor
- Número de teléfono: +82-340-7022
- Correo electrónico: kimwook@catholic.ac.kr
-
Contacto:
- Junhyun Lee, Instructor
- Número de teléfono: +82-340-7026
- Correo electrónico: surgeryjun@catholic.ac.kr
-
-
Kyunggi-do
-
Pucheon, Kyunggi-do, Corea, república de, 420-717
- Activo, no reclutando
- Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
|
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.
Otros nombres:
|
|
Comparador activo: 2
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
2 year survival
Periodo de tiempo: two year
|
two year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
efficacy and clinical out come
Periodo de tiempo: two year
|
two year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Wook Kim, Professor, Department of Surgery, Holy Family Hospital. The Catholic University of Korea
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- Nakajima T. Gastric cancer treatment guidelines in Japan. Gastric Cancer. 2002;5(1):1-5. doi: 10.1007/s101200200000.
- 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.
- Ageno W, Squizzato A, Garcia D, Imberti D. Epidemiology and risk factors of venous thromboembolism. Semin Thromb Hemost. 2006 Oct;32(7):651-8. doi: 10.1055/s-2006-951293.
- 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.
- Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Surgical treatment of advanced gastric cancer: Japanese perspective. Dig Surg. 2007;24(2):101-7. doi: 10.1159/000101896. Epub 2007 Apr 19.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2008
Finalización primaria (Anticipado)
1 de julio de 2013
Finalización del estudio (Anticipado)
1 de julio de 2013
Fechas de registro del estudio
Enviado por primera vez
25 de agosto de 2008
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2008
Publicado por primera vez (Estimar)
26 de agosto de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de diciembre de 2008
Última actualización enviada que cumplió con los criterios de control de calidad
30 de diciembre de 2008
Última verificación
1 de agosto de 2008
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HFHGS01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .