Stomach NeoplasmNCT05007912
Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy
An observational study of Stomach Neoplasm, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy. Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Esophagojejunostomy type
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2021to 21 Jun 2023
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients involving the upper stomach
Who may be able to join
- Diagnosed as gastric adenocarcinoma
- Involving the esophagogastric junction or gastric cardia
- Age 18 - 80 years
- Anticipated to undergo laparoscopic total or proximal gastrectomy
- cT1-T4a
Who cannot join
- Previous history of gastrectomy
- Neoadjuvant chemotherapy or radiotherapy for gastric cancer
- Invasion to other organs
- Open conversion
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
So Hyun Kang, +82-31-787-7099, shkang@snubh.org
About this study
Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy.
Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.
- Conditions
- Stomach Neoplasm
- Being tested
- Esophagojejunostomy type
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagojejunostomy typeProcedure or surgery
Use of either circular or linear stapler
| Study group | Role | What they receive |
|---|---|---|
| Orvil Group | Group that used the Orvil (circular stapler) for esophagojejunostomy Receives: Procedure: Esophagojejunostomy type | |
| Linear Group | Group that used the linear stapler for esophagojejunostomy Receives: Procedure: Esophagojejunostomy type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis complication
including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start21 Jun 2021
- Primary completion21 Jun 2023 (estimated)
- Study completion21 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Ho Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007912
- Sponsor's protocol ID
- SNUBH_EJ
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy
- ClinicalTrials.gov ID
- NCT05007912
- Acronym / sponsor ID
- SNUBH_EJ
- Conditions
- Stomach Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 21 Jun 2023 (estimated)
- First posted
- 17 Aug 2021 (actual)
- 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.
Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy.
Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orvil Group | – | Procedure: Esophagojejunostomy typeGroup that used the Orvil (circular stapler) for esophagojejunostomy |
| Linear Group | – | Procedure: Esophagojejunostomy typeGroup that used the linear stapler for esophagojejunostomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients involving the upper stomach
Key inclusion criteria (5 listed)
- Diagnosed as gastric adenocarcinoma
- Involving the esophagogastric junction or gastric cardia
- Age 18 - 80 years
- Anticipated to undergo laparoscopic total or proximal gastrectomy
- cT1-T4a
Key exclusion criteria (4 listed)
- Previous history of gastrectomy
- Neoadjuvant chemotherapy or radiotherapy for gastric cancer
- Invasion to other organs
- Open conversion
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 |
|---|---|---|
| Esophagojejunostomy typeUse of either circular or linear stapler | Procedure or surgery | Linear Group, Orvil Group |
Primary outcome
Anastomosis complication
Time frame: within 1 year
including anastomosis leakage, stenosis, bleeding of the esophagojejunostomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasm, run by Seoul National University Bundang Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So Hyun Kang (+82-31-787-7099, shkang@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis complication (time frame: within 1 year). 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 17 Aug 2021.