Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085031
• Other study ID #: NFGS-OrVil-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 7, 2014
• Last updated: April 8, 2014
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, M.D., Ph.D.
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomosis
• Minimally Invasive Surgery
• Stomach Neoplasms

Intervention

Procedure:
• Intracorporeal Roux-en-Y esophagojejunostomy
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
• Extracorporeal Roux-en-Y esophagojejunostomy
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomosis-related early complication rate	Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.	30 days	Yes
Secondary	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.	During operation	No
Secondary	Morbidity and mortality rates	The early postoperative complication was defined as the event observed within 30 days after surgery.	30 days	Yes
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course.	2 weeks	No
Secondary	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.	6 months	No

External Links

•   Chinese Anti-Cancer Association
•   Nanfang Hospital, China
•   Southern Medical University, China