Colonic PolypNCT05190042
Clinical Study on Continuous Suture of Endoscopic Mucosal Defects
A study testing Cotinuous suture and Clips in people with Colonic Polyp and Gastrointestinal Neoplasms, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp, Gastrointestinal Neoplasms
- What is being tested?
- Cotinuous suture and Clips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to 30 Jul 2022
- 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
- The indications for endoscopic resection were large (≥20mm in diameter), nonpedunculated, benign, and early malignant mucosal or submucosal gastric or colorectal lesions.
- Written informed consent
Who cannot join
- The tumor has spread to the muscularis layer, lymph nodes, or distal metastases;
- Multiple lesions (≥20mm in diameter) ;
- Underlying bleeding disorder;
- The platelet count less than 50×10^9/L;
- Serious cardio-pulmonary, hepatic or renal disease;
- Intolerance to endoscopy;
- Other high-risk conditions or disease (such as massive ascites, etc.);
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of Chinese PLA General Hosptial
Beijing, Beijing Municipality, 100039
About this study
Official title: Clinical Study on Continuous Suture of Mucosal Defects After Endoscopic Mucosal Lesion Resection
The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after ESD/EMR. In this study, a clinical randomized controlled study was conducted in our hospital. A total of 62 enrolled patients were divided into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The complete mucosal/submucosa defects closure rates were the primary outcome.
Read the detailed description
Endoscopic submucosal resection (EMR) or submucosal dissection (ESD) for gastrointestinal lesions were used to treat early gastrointestinal cancer or large benign polyps, and their complete resection rates were high, which greatly reduce unnecessary surgical operations. However, after endoscopic resection of mucosal/submucosal lesions, large mucosal/submucosal defects may be created. These defects may cause more delayed postoperative adverse events (bleeding, perforation). The use of clips to completely seal the mucosal defect after gastrointestinal mucosal/submucosal lesion resection can significantly reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The surgical sutures combined with clips to close the mucosal defect after surgery significantly increased the complete closure rates of the post-EMR/ESD mucosal/submucosal defect. This study intends to further determine its safety and effectiveness through a clinical randomized controlled study, and standardize indications and contraindications. A total of 62 enrolled patients were allocated into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The primary outcome was complete mucosal/submucosa defects closure rates. The secondary outcomes were the closure time, closure speed, and immediate bleeding during the operation as well as delayed bleeding, delayed perforation, and polyps syndrome after resection.
- Conditions
- Colonic Polyp, Gastrointestinal Neoplasms
- Being tested
- Cotinuous suture, Clips
- Keywords
- Endoscopic mucosal resection, Endoscopic submucosal dissection, Gastrolintestinal polyps, Continuous suture, Clips
- Medical subject headings
- Colonic Polyps, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotinuous sutureDevice
Cotinuous suture using surgery thread
ClipsDevice
Hemostatic clips
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture group | Experimental | Surgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects.
This group was set as a experimental group. Receives: Device: Cotinuous suture |
| Clips group | Active comparator | Clips were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a control group. Receives: Device: Clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of complete closure of mucosal/submucosal defects
When the clips were applied next to each other and there were no substantial submucosal areas in the closure line
Measured: 1day
Secondary outcomes (6)
The duration time of closure
The duration of closure was defined as the interval from insertion of the first clip until complete or incomplete closure
Measured: 1 day
The closure speed
The closure speed was defined as the resection area divided by 10x the duration of the ligation procedure (cm2 /10 minutes).
Measured: 1day
Immediate bleeding
Immediate bleeding refers to those episodes of hemorrhage that occurred during the procedure and lasted more than 30 seconds or required endoscopic treatment.
Measured: 1 day
Delayed bleeding
Delayed bleeding was defined as bleeding requiring emergency endoscopic hemostasis or transfusion or the presence of hemoglobin loss≥2 g/dL after EMR/ESD
Measured: 14 days
Delayed perforation
Delayed perforation was defined as the presence of free air on abdominal CT or radiography after completion of the procedure in patients without perforation during EMR/ESD and no symptoms of peritoneal irritation after EMR/ESD
Measured: 14 days
Post polypectomy syndrome
Post polypectomy syndrome was defined by symptoms of pain, fever, leukocytosis, peritoneal tenderness, and guarding.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start18 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- 62 participants (actual)
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, MD, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190042
- Sponsor's protocol ID
- 307-GIE-Suture
- Status last verified
- Mar 2024
- First submitted
- 23 Nov 2021
- Last updated
- 2 Apr 2024
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Continuous Suture of Mucosal Defects After Endoscopic Mucosal Lesion Resection
- ClinicalTrials.gov ID
- NCT05190042
- Acronym / sponsor ID
- 307-GIE-Suture
- Conditions
- Colonic Polyp, Gastrointestinal Neoplasms
- Keywords
- Endoscopic mucosal resection, Endoscopic submucosal dissection, Gastrolintestinal polyps, Continuous suture, Clips
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 13 Jan 2022 (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.
The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after ESD/EMR. In this study, a clinical randomized controlled study was conducted in our hospital. A total of 62 enrolled patients were divided into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The complete mucosal/submucosa defects closure rates were the primary outcome.
Detailed description
Endoscopic submucosal resection (EMR) or submucosal dissection (ESD) for gastrointestinal lesions were used to treat early gastrointestinal cancer or large benign polyps, and their complete resection rates were high, which greatly reduce unnecessary surgical operations. However, after endoscopic resection of mucosal/submucosal lesions, large mucosal/submucosal defects may be created. These defects may cause more delayed postoperative adverse events (bleeding, perforation). The use of clips to completely seal the mucosal defect after gastrointestinal mucosal/submucosal lesion resection can significantly reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The surgical sutures combined with clips to close the mucosal defect after surgery significantly increased the complete closure rates of the post-EMR/ESD mucosal/submucosal defect. This study intends to further determine its safety and effectiveness through a clinical randomized controlled study, and standardize indications and contraindications. A total of 62 enrolled patients were allocated into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The primary outcome was complete mucosal/submucosa defects closure rates. The secondary outcomes were the closure time, closure speed, and immediate bleeding during the operation as well as delayed bleeding, delayed perforation, and polyps syndrome after resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture group | Experimental | Device: Cotinuous sutureSurgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a experimental group. |
| Clips group | Active comparator | Device: ClipsClips were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The indications for endoscopic resection were large (≥20mm in diameter), nonpedunculated, benign, and early malignant mucosal or submucosal gastric or colorectal lesions.
- Written informed consent
Key exclusion criteria (8 listed)
- The tumor has spread to the muscularis layer, lymph nodes, or distal metastases;
- Multiple lesions (≥20mm in diameter) ;
- Underlying bleeding disorder;
- The platelet count less than 50×10^9/L;
- Serious cardio-pulmonary, hepatic or renal disease;
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 |
|---|---|---|
| Cotinuous sutureCotinuous suture using surgery thread | Device | Continuous suture group |
| ClipsHemostatic clips | Device | Clips group |
Primary outcome
The rates of complete closure of mucosal/submucosal defects
Time frame: 1day
When the clips were applied next to each other and there were no substantial submucosal areas in the closure line
6 secondary outcomes
The duration time of closure
Time frame: 1 day
The closure speed
Time frame: 1day
Immediate bleeding
Time frame: 1 day
Delayed bleeding
Time frame: 14 days
Delayed perforation
Time frame: 14 days
Post polypectomy syndrome
Time frame: 14 days
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 2 Apr 2024.
- 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, MD principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotinuous suture and Clips in people with Colonic Polyp and Gastrointestinal Neoplasms, 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 2 inclusion and 8 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 2 Apr 2024. 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?
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?
The rates of complete closure of mucosal/submucosal defects (time frame: 1day). 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 2 Apr 2024.