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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2

Conditions: Minimally Invasive Surgery; Anastomosis; Stomach Neoplasms

Treatments: Procedure: Extracorporeal Roux-en-Y esophagojejunostomy; Procedure: Intracorporeal Roux-en-Y esophagojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02085031

NFGS-OrVil-01

Details and patient eligibility

About

• 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Intracorporeal Roux-en-Y esophagojejunostomy

Experimental group

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.

Treatment:

Procedure: Intracorporeal Roux-en-Y esophagojejunostomy

Extracorporeal Roux-en-Y esophagojejunostomy

Active Comparator group

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.

Treatment:

Procedure: Extracorporeal Roux-en-Y esophagojejunostomy