Gastric CancerNCT02330913
Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy
A study testing Intracorporeal esophagojejunostomy in people with Gastric Cancer, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Intracorporeal esophagojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Simultaneous malignancy in other organ
- Experience of previous laparotomy
- Experience of gastric resection including wedge resection
- Vulnerable subject
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
Official title: Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy: π-shape Esophagojejunostomy, Three-in-one Technique
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
- Being tested
- Intracorporeal esophagojejunostomy
- Keywords
- total gastrectomy, intracorporeal, totally laparoscopic, esophagojejunostomy, anastomosis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal esophagojejunostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal esophagojejunostomy | Experimental | Patient group with intracorporeal esophagojejunostomy with linear stapler Receives: Procedure: Intracorporeal esophagojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis related complication rate
Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication
Measured: During 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Wan Ryu, Keimyung University Dongsan Medical Center
- Investigators
- Seung Wan Ryu, Ph.D., Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330913
- Sponsor's protocol ID
- 2014-11-001
- Status last verified
- Dec 2015
- First submitted
- 19 Dec 2014
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy: π-shape Esophagojejunostomy, Three-in-one Technique
- ClinicalTrials.gov ID
- NCT02330913
- Acronym / sponsor ID
- 2014-11-001
- Conditions
- Gastric Cancer
- Keywords
- total gastrectomy, intracorporeal, totally laparoscopic, esophagojejunostomy, anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal esophagojejunostomy | Experimental | Procedure: Intracorporeal esophagojejunostomyPatient group with intracorporeal esophagojejunostomy with linear stapler |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Simultaneous malignancy in other organ
- Experience of previous laparotomy
- Experience of gastric resection including wedge resection
- Vulnerable subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracorporeal esophagojejunostomyUnder 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. | Procedure or surgery | Intracorporeal esophagojejunostomy |
Primary outcome
Anastomosis related complication rate
Time frame: During 30 days after operation
Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Wan Ryu, Ph.D. principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal esophagojejunostomy in people with Gastric Cancer, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis related complication rate (time frame: During 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.