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OpenTrials
Completed

NCT Number: NCT02330913

Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anastomosis related complication rate

    Time frame: During 30 days after operation

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

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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