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Sponsored by: |
The Catholic University of Korea |
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Information provided by: | The Catholic University of Korea |
ClinicalTrials.gov Identifier: | NCT00622804 |
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
Condition | Intervention | Phase |
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Stomach Cancer Gastrectomy |
Procedure: Billroth-II (B-II) Procedure: Roux en Y gastrojejunostomy (RY-GJ) Procedure: uncut Roux en Y gastrojejunostomy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Billroth-II (B-II)reconstruction
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Procedure: Billroth-II (B-II)
After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.
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2
Roux en Y gastrojejunostomy (RY-GJ)
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Procedure: Roux en Y gastrojejunostomy (RY-GJ)
After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.
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3
uncut Roux en Y gastrojejunostomy (uncut RY-GJ)
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Procedure: uncut Roux en Y gastrojejunostomy
After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.
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Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.
We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.
From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
Exclusion Criteria:
Patients following criteria:
Contact: Wook Kim, MD, PhD | +82-32-340-7022 | kimwook@catholic.ac.kr |
Contact: Hoon Hur, MD | +82-2-3472-6320 | hhcmc75@naver.com |
Korea, Republic of | |
Department of Surgery, St Mary's Hospital, The Catholic University of Korea | Not yet recruiting |
Seoul, Korea, Republic of, 150-713 | |
Contact: Hae Myung Jeon, MD, PhD +82-2-3779-2020 hmjeon@catholic.ac.kr | |
Contact: Hoon Hur, MD +82-2-3779-1175 hhcmc75@naver.com | |
Principal Investigator: Hae Myung Jeon, MD, PhD | |
Sub-Investigator: Hoon Hur, MD | |
Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea | Not yet recruiting |
Seoul, Korea, Republic of, 137-710 | |
Contact: Cho Hyun Park, MD, PhD +82-2-590-2727 chpark@catholic.ac.kr | |
Contact: Kyo Young Song, MD +82-2-590-2727 skygs@catholic.ac.kr | |
Principal Investigator: Cho Hyun Park, MD, PhD | |
Sub-Investigator: Kyo Young Song, MD | |
Sub-Investigator: Ie Ryung Yoo, MD, PhD | |
Sub-Investigator: Dong Jea Kim, PhD | |
Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea | Recruiting |
In Cheon, Korea, Republic of, 403-720 | |
Contact: Seung Man Park, MD, PhD +82-32-510-5690 smpark@olmh.cuk.ac.kr | |
Principal Investigator: Seung Man Park, MD, PhD | |
Sub-Investigator: Jin Jo Kim, MD | |
Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea | Recruiting |
Suwon, Korea, Republic of, 442-723 | |
Contact: Hyung-Min Chin, MD, PhD +82-31-249-7170 hchin@catholic.ac.kr | |
Principal Investigator: Hyung-Min Chin, MD,PhD | |
Sub-Investigator: Kyong-Hwa Jun, MD | |
Department of Surgery, Holy Family Hospital, The Catholic University of Korea | Recruiting |
Bucheon, Korea, Republic of, 420-717 | |
Contact: Wook Kim, MD, PhD +82-32-340-7022 kimwook@catholic.ac.kr | |
Principal Investigator: Wook Kim, MD, PhD |
Principal Investigator: | Wook Kim, MD, PhD | Department of Surgery, Holy Family Hospital, The Catholic University of Korea |
Responsible Party: | Department of Surgery, Holy Family Hospital, College of Medicine ( Wook Kim ) |
Study ID Numbers: | HCHC06OT049 |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622804 |
Health Authority: | Korea: Food and Drug Administration |
Stomach cancer Gastrectomy Postgastrectomy syndrome |
Digestive System Neoplasms Gastrointestinal Diseases Stomach cancer Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases |
Bile Reflux Stomach Neoplasms Biliary Tract Diseases Gastrointestinal Neoplasms Neurologic Manifestations Gastroparesis |
Neoplasms Neoplasms by Site Duodenogastric Reflux |