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Trial Title:
Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
NCT ID:
NCT02085031
Condition:
Stomach Neoplasms
Minimally Invasive Surgery
Anastomosis
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Roux-en-Y Anastomosis
laparoscopic surgery
minilaparotomy
stomach neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intracorporeal Roux-en-Y esophagojejunostomy
Description:
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy
intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
Arm group label:
Intracorporeal Roux-en-Y esophagojejunostomy
Intervention type:
Procedure
Intervention name:
Extracorporeal Roux-en-Y esophagojejunostomy
Description:
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally
using a transabdominally inserted anvil will be performed.
Arm group label:
Extracorporeal Roux-en-Y esophagojejunostomy
Summary:
- To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular
stapler was the most common used method during laparoscopy-assisted total
gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery
in which intracorporeal anastomosis should be performed.
- To gain potential clinical benefits from a smaller length of minilaparotomy and an
easier anastomosis technique than extracorporeal anastomosis, intracorporeal
Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally
laparoscopic total gastrectomy was adopted by experienced surgeons recently.
- However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a
transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study
comparing the safety of intracorporeal versus extracorporeal Roux-en-Y
esophagojejunostomy by circular stapler based on a well designed randomized
controlled trial is needed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- Tumor located at middle or upper third of stomach while laparoscopic total
gastrectomy is the planning surgery
- Tumor invasion is less than 3cm above the esophagogastric junction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I, II, or III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Conversion to open surgery before reconstruction
Gender:
All
Minimum age:
19 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510-515
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoxin Li, M.D., Ph.D.
Phone:
+86-138-0277-1450
Email:
gzliguoxin@163.com
Contact backup:
Last name:
Yanfeng Hu, M.D.
Phone:
+86-136-3249-4551
Email:
huyanfenger@vip.tom.com
Investigator:
Last name:
Guoxin Li, M.D.,Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Jiang Yu, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yanfeng Hu, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tingyu Mou, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Zhenwei Deng, M.D.
Email:
Sub-Investigator
Start date:
April 2014
Completion date:
December 2015
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02085031
http://www.fimmu.com/index_com.html
http://www.nfyy.com
http://www.caca.org.cn
