Gastroduodenal AnastomosisNCT02193789
Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration
A study testing deployment of through the scope covered metallic stent at the stricture site and Covered Self-expandable Metallic Stents in people with Gastroduodenal Anastomosis, run by Ajou University School of Medicine at 2 sites in South Korea.
Trial summary
In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastroduodenal Anastomosis
- What is being tested?
- deployment of through the scope covered metallic stent at the stricture site and Covered Self-expandable Metallic Stents
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2014to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subtotal gastrectomy with Billroth-I or Billroth-II anastomosis
- symptom of gastric outlet obstruction
- anastomosis site stricture after surgery
Who cannot join
- patients of the impossible stent insertion due to other complication
- foreigner
- no agree a concent
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Ajou university hospital
Suwon, Gyeong-gi Do, 443-380
Ajou University Hospital
Suwon, 443-721
About this study
Official title: The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study
In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.
- Conditions
- Gastroduodenal Anastomosis
- Being tested
- deployment of through the scope covered metallic stent at the stricture site, Covered Self-expandable Metallic Stents
- Keywords
- Anastomosis site structure, Stent insertion, Stent migration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deployment of through the scope covered metallic stent at the stricture siteProcedure or surgery
Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site
Covered Self-expandable Metallic StentsDevice
| Study group | Role | What they receive |
|---|---|---|
| Anastomosis site stricture | Experimental | anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis Receives: Procedure: deployment of through the scope covered metallic stent at the stricture site; Device: Covered Self-expandable Metallic Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptom (Resolving anastomosis site stricture)
Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.
Measured: Up to 1 month
Secondary outcomes (1)
Complications associated with the procedure
Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.)
Measured: Up to 1 month (time of stent removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroduodenal AnastomosisStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kee Myung Lee, Ajou University School of Medicine
- Investigators
- Sun Gyo Lim, M.D., Principal investigator, Ajou University School of MedicineKi Seong Lee, M.D., Principal investigator, Ajou University School of MedicineJoon Koo Kang, M.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193789
- Sponsor's protocol ID
- AJIRB-MED-MDB-14-059
- Status last verified
- Feb 2016
- First submitted
- 1 Jul 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT02193789
- Acronym / sponsor ID
- AJIRB-MED-MDB-14-059
- Conditions
- Gastroduodenal Anastomosis
- Keywords
- Anastomosis site structure, Stent insertion, Stent migration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jul 2014 (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.
In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anastomosis site stricture | Experimental | Procedure: deployment of through the scope covered metallic stent at the stricture site, Device: Covered Self-expandable Metallic Stentsanastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subtotal gastrectomy with Billroth-I or Billroth-II anastomosis
- symptom of gastric outlet obstruction
- anastomosis site stricture after surgery
Key exclusion criteria (3 listed)
- patients of the impossible stent insertion due to other complication
- foreigner
- no agree a concent
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 |
|---|---|---|
| deployment of through the scope covered metallic stent at the stricture siteDeployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site | Procedure or surgery | Anastomosis site stricture |
| Covered Self-expandable Metallic Stents | Device | Anastomosis site stricture |
Primary outcome
Improvement of symptom (Resolving anastomosis site stricture)
Time frame: Up to 1 month
Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.
1 secondary outcome
Complications associated with the procedure
Time frame: Up to 1 month (time of stent removal)
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 22 Feb 2016.
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.
Sun Gyo Lim, M.D. principal investigator
Ajou University School of Medicine
Ki Seong Lee, M.D. principal investigator
Ajou University School of Medicine
Joon Koo Kang, M.D. principal investigator
Ajou University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deployment of through the scope covered metallic stent at the stricture site and Covered Self-expandable Metallic Stents in people with Gastroduodenal Anastomosis, run by Ajou University School of Medicine at 2 sites 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 3 inclusion and 3 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement of symptom (Resolving anastomosis site stricture) (time frame: Up to 1 month). 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 22 Feb 2016.