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Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
Conditions
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
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intracorporeal Roux-en-Y esophagojejunostomy
Type: Procedure
Name: Extracorporeal Roux-en-Y esophagojejunostomy
Type: Procedure
Overall Status
Recruiting
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.
- 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
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 19 Years
Gender: Both
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
- 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
Location
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Guoxin Li, M.D., Ph.D. - +86-138-0277-1450 - gzliguoxin@163.com
Start Date
April 2014
Completion Date
December 2015
Sponsors
Nanfang Hospital of Southern Medical University
Source
Nanfang Hospital of Southern Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page