Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Intracorporeal esophagojejunostomy

• Registration Number: NCT02330913
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal resection and closure of common entry hole after anastomosis) was performed with only one stapler. Therefore, the novel method is simple and fast. Also, this new technique is better economically than previously introduced anastomosis using linear stapler because lesser number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal anastomosis method during laparoscopic total gastrectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-24
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Histologically confirmed adenocarcinoma in stomach
• Males or Females, aged≥20 years and ≤80 years
• Without serosa invasion, extraperigastric lymph node metastasis and other organ metastasis stage in preoperative evaluation, (cT1-3N0-1M0)
• Beyond the indication of ESD
• Tumor location in high body of stomach or requiring total gastrectomy
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
• American Society of Anesthesiolosists (ASA) score of 1 to 3
• The patient has given their written informed consent to participate in the study

Exclusion Criteria

• Simultaneous malignancy in other organ
• Experience of previous laparotomy
• Experience of gastric resection including wedge resection
• Vulnerable subject

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracorporeal esophagojejunostomy	Intracorporeal esophagojejunostomy	Patient group with intracorporeal esophagojejunostomy with linear stapler

Primary Outcome Measures

Name	Time	Method
Anastomosis related complication rate	During 30 days after operation	Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of