Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy: π-shape Esophagojejunostomy, Three-in-one Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330913
• Other study ID #: 2014-11-001
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: December 24, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Procedure:
• Intracorporeal esophagojejunostomy
Under laparoscopic view, esophagojejunostomy was pereformed with 60mm linear stapler on right side of distal esophagus like as functional end-to-end fashion before esophageal and jejunal resection. Then, three procedures of esophageal resection, common entry hole closure and jejunal resection was performed with a single use of 60mm stapler. Also, jejunojejunostomy was also performed via already made staple entry hole.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomosis related complication rate	Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication	During 30 days after operation	Yes