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Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

NCT ID: NCT02330913

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Gastric Cancer

Keywords

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total gastrectomy intracorporeal totally laparoscopic esophagojejunostomy anastomosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracorporeal esophagojejunostomy

Patient group with intracorporeal esophagojejunostomy with linear stapler

Group Type EXPERIMENTAL

Intracorporeal esophagojejunostomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seung Wan Ryu

Director of Gastrointesinal surgery, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung Wan Ryu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

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Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-11-001

Identifier Type: -

Identifier Source: org_study_id