InterventionNCT03053232
Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
A study testing Purse string suture device and Endoclips in people with Intervention and Gastrointestinal Perforation, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervention, Gastrointestinal Perforation
- What is being tested?
- Purse string suture device and Endoclips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 Years
- Immediate procedure associated gastrointestinal perforation (i.e. post-ESD perforation, post-EMR perforation；complications of endoscopic examination and procedure)
- American Society of Anesthesiology risk class 1, 2 or 3
Who cannot join
- Patients <18 years
- Patients with thrombocytopenia (platelet count < 50,000/microL) or elevated - International Normalized Ratio (INR > 1.5)
- Hemodynamic instability
- Pregnancy and lactation
- Patients who are unable or unwilling to give an informed consent
- Chronic fistula following abdominal surgery
- Pyriform fossa perforation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071
Yan Liu, +86-010-66947473, 13911798288@163.com
Min Min, M.D.
About this study
Official title: Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers. Endoscopic procedure associated gastrointestinal perforation is one of the the most severe complications, which is associated with high morality and needs timely detection and effective treatment in clinical practice.Over 90% procedure associated gastrointestinal perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been widely used in closing the immediate gastrointestinal perforations, but the location of the endoclips could influence the effective rate, limiting its application. In addition, multiple endoclips should be placed under endoscopy for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such patients with procedure associated gastrointestinal perforations. Clinical data validated that the usage of this new purse string suture in treating immediate procedure associated perforations was greatly convenient and effective with very low reoperation rate and postoperative complication rate. A specially designed loop was equipped in this device, which could be tightened under endoscopy. Thus, compared with the placement of endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations.This study will test whether purse string suture device will increase the effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder endoscopyin a randomized controlled trialby comparing the use of purse string suture deviceand endoclips.
Read the detailed description
This is a randomized controlled trial comparing the use of purse string suture device versus endoclips for closing procedure associated gastrointestinal perforation under endoscopy, which is one of the most severe complications and needs timely treatment. Endoclips have been widely used in closing the gastrointestinal perforations, but the location of the endoclips could significantly influence the effective rate. In addition, multiple endoclips will be needed for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device has been developed and introduced to the clinicalmanagement of such patients with gastrointestinal perforations. A loop was equipped in this device, which could be tightened. Thus, compared with endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations. This study will test whether purse string suture device will increase the effectiveness of treating procedure associated gastrointestinal perforations under endoscopy in a randomized controlled trial.
- Conditions
- Intervention, Gastrointestinal Perforation
- Being tested
- Purse string suture device, Endoclips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse string suture deviceDevice
Using purse string suture device to close gastrointestinal perforation under endoscopy.
EndoclipsDevice
Using endoclips to close gastrointestinal perforation under endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Purse string suture device | Experimental | Use of purse string suture device to close gastrointestinal perforation. Receives: Device: Purse string suture device |
| Endoclips | Active comparator | Use of endoclips to close gastrointestinal perforation. Receives: Device: Endoclips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technique success rate
Percentage of patients who successfully receive endoscopical interventions
Measured: 1 year
Secondary outcomes (8)
Effective rate
Percentage of patients whose clinical symptoms are alleviated and perforations closed
Measured: 1 year
Postoperative complication rate
Percentage of patients who have complications including death after procedure
Measured: 1 year
Reoperation rate
Percentage of patients who need a secondary operation
Measured: 1 year
Operation time
The time length of the endoscopic operation will be recorded in the unit of minute.
Measured: 1 year
Postoperative pain
Postoperative pain will be evaluated on a visula analogue score (VAS).
Measured: 1 year
Postoperative hospitalization
The length of the hospitalizatioin after operation will be recorded in the unit of day.
Measured: 1 year
Time to resume diet
When the patients resume diet will be monitored and recorded.
Measured: 1 year
Medical cost
The medical cost for the operation and hospitalization will be recorded and collected.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Feb 2017
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InterventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, M.D., Ph.D., Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053232
- Sponsor's protocol ID
- 307-LM
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.
PubMed 26441181Tan S, Wu G, Zhuang Q, Xi Q, Meng Q, Jiang Y, Han Y, Yu C, Yu Z, Li N. Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials. Int J Surg. 2016 Sep;33 Pt A:124-32. doi: 10.1016/j.ijsu.2016.07.077. Epub 2016 Aug 5.
PubMed 27504848
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
- ClinicalTrials.gov ID
- NCT03053232
- Acronym / sponsor ID
- 307-LM
- Conditions
- Intervention, Gastrointestinal Perforation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Feb 2017 (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.
Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers. Endoscopic procedure associated gastrointestinal perforation is one of the the most severe complications, which is associated with high morality and needs timely detection and effective treatment in clinical practice.Over 90% procedure associated gastrointestinal perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been widely used in closing the immediate gastrointestinal perforations, but the location of the endoclips could influence the effective rate, limiting its application. In addition, multiple endoclips should be placed under endoscopy for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such patients with procedure associated gastrointestinal perforations. Clinical data validated that the usage of this new purse string suture in treating immediate procedure associated perforations was greatly convenient and effective with very low reoperation rate and postoperative complication rate. A specially designed loop was equipped in this device, which could be tightened under endoscopy. Thus, compared with the placement of endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations.This study will test whether purse string suture device will increase the effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder endoscopyin a randomized controlled trialby comparing the use of purse string suture deviceand endoclips.
Detailed description
This is a randomized controlled trial comparing the use of purse string suture device versus endoclips for closing procedure associated gastrointestinal perforation under endoscopy, which is one of the most severe complications and needs timely treatment. Endoclips have been widely used in closing the gastrointestinal perforations, but the location of the endoclips could significantly influence the effective rate. In addition, multiple endoclips will be needed for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device has been developed and introduced to the clinicalmanagement of such patients with gastrointestinal perforations. A loop was equipped in this device, which could be tightened. Thus, compared with endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations. This study will test whether purse string suture device will increase the effectiveness of treating procedure associated gastrointestinal perforations under endoscopy in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purse string suture device | Experimental | Device: Purse string suture deviceUse of purse string suture device to close gastrointestinal perforation. |
| Endoclips | Active comparator | Device: EndoclipsUse of endoclips to close gastrointestinal perforation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 Years
- Immediate procedure associated gastrointestinal perforation (i.e. post-ESD perforation, post-EMR perforation；complications of endoscopic examination and procedure)
- American Society of Anesthesiology risk class 1, 2 or 3
Key exclusion criteria (7 listed)
- Patients <18 years
- Patients with thrombocytopenia (platelet count < 50,000/microL) or elevated - International Normalized Ratio (INR > 1.5)
- Hemodynamic instability
- Pregnancy and lactation
- Patients who are unable or unwilling to give an informed consent
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 |
|---|---|---|
| Purse string suture deviceUsing purse string suture device to close gastrointestinal perforation under endoscopy. | Device | Purse string suture device |
| EndoclipsUsing endoclips to close gastrointestinal perforation under endoscopy. | Device | Endoclips |
Primary outcome
Technique success rate
Time frame: 1 year
Percentage of patients who successfully receive endoscopical interventions
8 secondary outcomes
Effective rate
Time frame: 1 year
Postoperative complication rate
Time frame: 1 year
Reoperation rate
Time frame: 1 year
Operation time
Time frame: 1 year
Postoperative pain
Time frame: 1 year
Postoperative hospitalization
Time frame: 1 year
Time to resume diet
Time frame: 1 year
Medical cost
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 26441181Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.
- Background: PubMed 27504848Tan S, Wu G, Zhuang Q, Xi Q, Meng Q, Jiang Y, Han Y, Yu C, Yu Z, Li N. Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials. Int J Surg. 2016 Sep;33 Pt A:124-32. doi: 10.1016/j.ijsu.2016.07.077. Epub 2016 Aug 5.
- 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.
Yan Liu, M.D., Ph.D. principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purse string suture device and Endoclips in people with Intervention and Gastrointestinal Perforation, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 7 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 15 Feb 2017. 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 China. 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 Xiaotian Sun, M.D., Ph.D. (+86-010-66947473, xiaotian-sun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technique success rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053232, which also lists 2 linked publications.
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 15 Feb 2017; AzTrials last refreshed its copy on 30 Oct 2026.