Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
Primary Purpose
Stomach Neoplasms, Minimally Invasive Surgery, Anastomosis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Intracorporeal Roux-en-Y esophagojejunostomy
Extracorporeal Roux-en-Y esophagojejunostomy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Roux-en-Y Anastomosis, laparoscopic surgery, minilaparotomy, stomach neoplasms
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
Sites / Locations
- Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intracorporeal Roux-en-Y esophagojejunostomy
Extracorporeal Roux-en-Y esophagojejunostomy
Arm Description
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed for the patients assigned to this arm.
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm.
Outcomes
Primary Outcome Measures
Anastomosis-related early complication rate
Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.
Secondary Outcome Measures
Reconstruction time
Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed.
Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed.
Morbidity and mortality rates
The early postoperative complication was defined as the event observed within 30 days after surgery.
Postoperative recovery course
Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course.
Postoperative quality of life
EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery.
Full Information
NCT ID
NCT02085031
First Posted
March 7, 2014
Last Updated
April 8, 2014
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02085031
Brief Title
Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
Official Title
Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Minimally Invasive Surgery, Anastomosis
Keywords
Roux-en-Y Anastomosis, laparoscopic surgery, minilaparotomy, stomach neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracorporeal Roux-en-Y esophagojejunostomy
Arm Type
Experimental
Arm Description
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed for the patients assigned to this arm.
Arm Title
Extracorporeal Roux-en-Y esophagojejunostomy
Arm Type
Active Comparator
Arm Description
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm.
Intervention Type
Procedure
Intervention Name(s)
Intracorporeal Roux-en-Y esophagojejunostomy
Intervention Description
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Roux-en-Y esophagojejunostomy
Intervention Description
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.
Primary Outcome Measure Information:
Title
Anastomosis-related early complication rate
Description
Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Reconstruction time
Description
Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed.
Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed.
Time Frame
During operation
Title
Morbidity and mortality rates
Description
The early postoperative complication was defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course.
Time Frame
2 weeks
Title
Postoperative quality of life
Description
EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanfeng Hu, M.D
Phone
+86-136-3249-4551
Email
huyanfenger@vip.tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Yanfeng Hu, M.D.
Phone
+86-136-3249-4551
Email
huyanfenger@vip.tom.com
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Jiang Yu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Yanfeng Hu, M.D.
First Name & Middle Initial & Last Name & Degree
Tingyu Mou, M.D.
First Name & Middle Initial & Last Name & Degree
Zhenwei Deng, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21993942
Citation
Marangoni G, Villa F, Shamil E, Botha AJ. OrVil-assisted anastomosis in laparoscopic upper gastrointestinal surgery: friend of the laparoscopic surgeon. Surg Endosc. 2012 Mar;26(3):811-7. doi: 10.1007/s00464-011-1957-x. Epub 2011 Oct 13.
Results Reference
background
PubMed Identifier
19343421
Citation
Jeong O, Park YK. Intracorporeal circular stapling esophagojejunostomy using the transorally inserted anvil (OrVil) after laparoscopic total gastrectomy. Surg Endosc. 2009 Nov;23(11):2624-30. doi: 10.1007/s00464-009-0461-z. Epub 2009 Apr 3.
Results Reference
background
PubMed Identifier
20953884
Citation
Kunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17.
Results Reference
background
PubMed Identifier
23211117
Citation
Jeong O, Jung MR, Kim GY, Kim HS, Ryu SY, Park YK. Comparison of short-term surgical outcomes between laparoscopic and open total gastrectomy for gastric carcinoma: case-control study using propensity score matching method. J Am Coll Surg. 2013 Feb;216(2):184-91. doi: 10.1016/j.jamcollsurg.2012.10.014. Epub 2012 Dec 2.
Results Reference
background
Links:
URL
http://www.fimmu.com/index_com.html
Description
Southern Medical University, China
URL
http://www.nfyy.com
Description
Nanfang Hospital, China
URL
http://www.caca.org.cn
Description
Chinese Anti-Cancer Association
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Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
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