Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

NCT02330913 | Completed

• 1 other identifier: 2014-11-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

total gastrectomy; intracorporeal; totally laparoscopic; esophagojejunostomy; anastomosis

Outcome Measures

Primary Outcomes (1)

• Anastomosis related complication rate

  Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication

  During 30 days after operation

Study Arms (1)

Intracorporeal esophagojejunostomy

EXPERIMENTAL

Patient group with intracorporeal esophagojejunostomy with linear stapler

Procedure: Intracorporeal esophagojejunostomy

Interventions

Intracorporeal esophagojejunostomy PROCEDURE

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.

Intracorporeal esophagojejunostomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Seung Wan Ryu, Ph.D.

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastrointesinal surgery, associate professor

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: January 5, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

KR (1)