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Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Intracorporeal esophagojejunostomy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring total gastrectomy, intracorporeal, totally laparoscopic, esophagojejunostomy, anastomosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Keimyung University Dongsan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intracorporeal esophagojejunostomy

Arm Description

Patient group with intracorporeal esophagojejunostomy with linear stapler

Outcomes

Primary Outcome Measures

Anastomosis related complication rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02330913

First Posted

December 19, 2014

Last Updated

December 24, 2015

Sponsor

Keimyung University Dongsan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02330913

Brief Title

Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

total gastrectomy, intracorporeal, totally laparoscopic, esophagojejunostomy, anastomosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intracorporeal esophagojejunostomy

Arm Type

Experimental

Arm Description

Patient group with intracorporeal esophagojejunostomy with linear stapler

Intervention Type

Procedure

Intervention Name(s)

Intracorporeal esophagojejunostomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Anastomosis related complication rate

Description

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

Time Frame

During 30 days after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung Wan Ryu, Ph.D.

Organizational Affiliation

Keimyung University Dongsan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keimyung University Dongsan Medical Center

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

12. IPD Sharing Statement

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Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

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