Gastric Submucosal TumorsNCT07305038
EDLS-clips in Endoscopic Full-thickness Resection
An observational study of Gastric Submucosal Tumors and Endoscopic Full Thickness Resection (EFTR), run by First Hospital of China Medical University at 1 site in China.
Trial summary
A retrospective analysis was conducted on patients who visited from March 2022 to May 2024 and underwent endoscopic full-thickness resection and double-layer suture with titanium clips under endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Submucosal Tumors, Endoscopic Full Thickness Resection (EFTR)
- What is being tested?
- endoscopic double-layer suturing method with metallic clips
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center from March 2022 to May 2024.
Who may be able to join
- Having a tumor located in the stomach and confirmed to originate from the muscularis propria on endoscopic ultrasonography (EUS);
- Having a tumor diameter >1 cm, which can be completely resected using endoscopic techniques, and with low risk of residue and recurrence;
- Preoperative assessment excluded those with lymph node or distant metastasis;
- Being able to tolerate tracheal intubation anesthesia, with no coagulation dysfunction or anticoagulant drugs stopped before EFTR.
Who cannot join
- Patients who have been evaluated preoperatively and are considered to have lymph node or distant metastasis;
- who cannot tolerate general anesthesia with endotracheal intubation,
- who have not discontinued anticoagulant drugs before EFTR or have coagulation dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Analysis of the Clinical Effect of EDLS-clips in Endoscopic Full-thickness Resection
A retrospective analysis was conducted on patients who visited from March 2022 to May 2024 and underwent endoscopic full-thickness resection and double-layer suture with titanium clips under endoscopy. The basic clinical information, tumor characteristics, overall resection rate and postoperative complications of all patients were evaluated. To analyze the clinical effect of double-layer suture technique with titanium clips under endoscopy in clamping the wound surface after full-thickness endoscopic resection.
Read the detailed description
The clinical data of patients who underwent endoscopic double-layer suture with titanium clip after endoscopic full-thickness resection at the Endoscopy Center of the First Affiliated Hospital of China Medical University from March 2022 to May 2024 were collected. Indications for endoscopic treatment of SMT: ① For tumors suspected of having malignant potential through preoperative examination or confirmed by biopsy pathology, especially for those suspected of having GIST with a preoperative long diameter of ≤2cm, low risk of recurrence and metastasis, and possibly complete resection, endoscopic resection can be performed. For suspected low-risk GIST with a tumor long diameter greater than 2cm and preoperative assessment excluding lymph node or distant metastasis, under the premise of ensuring complete tumor resection, endoscopic resection can be considered to be carried out by experienced endoscopists in units with mature endoscopic treatment techniques. ② SMT with symptoms (such as bleeding, obstruction). ③ Patients who are suspected of being benign by preoperative examination or confirmed by pathology, but cannot be followed up regularly or whose tumors increase in a short period of time during the follow-up period, or who have a strong willingness for endoscopic treatment. When the tumor protrudes into the serosa or partially grows outside the cavity, or when it is found during the operation that the tumor is closely adhered to the serosa layer and cannot be separated, EFTR can be selected for endoscopic treatment. Complications related to SMT in endoscopic treatment: (1) Intraoperative bleeding: Bleeding that causes the patient's hemoglobin to drop by more than 20g/L. (2) Postoperative bleeding: Postoperative bleeding is manifested as hematemesis, melena or hematochezia, etc. In severe cases, there may be manifestations of hemorrhagic shock. It mostly occurs within one week after the operation, but it can also appear 2 to 4 weeks after the operation. (3) Delayed perforation: It is usually manifested as abdominal distension, aggravated abdominal pain, signs of peritonitis, fever, and imaging examination shows gas accumulation or an increase in gas accumulation compared to before. (4) Gas-related complications: including subcutaneous emphysema, mediastinal emphysema, pneumothorax and pneumoperitoneum, etc. (5) Digestive tract fistula: Digestive juices caused by endoscopic surgery flow into the thoracic or abdominal cavity through the leakage channel. From a patient's medical records collected in the patient's age, gender, lesion characteristics, endoscopic treatment and postoperative clinical course details and other information. The investigators define the position of the lesion on the short axis as the position of the lesion center. The closure time is defined as the period from the start (when the investigators insert the clamp into the visual field channel) to the end of closure (when the last clamp is released).
- Being tested
- endoscopic double-layer suturing method with metallic clips
- Keywords
- endoscopic submucosal dissection, endoscopic full-thickness resection, endoscopic double-layer suturing method with metallic clips, submucosal tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic double-layer suturing method with metallic clipsProcedure or surgery
This study comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center.
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete closure rate of EDLS-clips
Successful closure refers to the full coverage of the mucosal defect by surrounding normal mucosa without any gaps.
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
Operative time
Operative time refers to the duration of the entire tumor resection and suture process (from the first incision of the mucosa with the knife to the completion of wound closure).
Measured: Perioperative/Periprocedural
Suturing time
Suturing time was defined as the period from when the operator inserts the first metallic clip through the instrument channel to close the wound until the release of the final metallic clip (for cases involving simultaneous cutting and suturing, the suturing time includes part of the tumor resection time).
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Mar 2022
- Primary completion31 May 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Submucosal TumorsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingliang Feng, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305038
- Sponsor's protocol ID
- End-D-F1
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Individual data sharing
- Yes: Investigators share the technical operation of this endoscopic double-layer suture method for closing the wounds after endoscopic full-thickness resection (EFTR) for gastric submucosal tumors (SMTs) using endoscopic double-layer suturing method using metal clips (EDLS-clips). This study included 43 patients with gastric SMTs who received EFTR and were treated with EDLS-clips from March 2022 to May 2024 at our center. The primary outcome was the complete closure rate by EDLS-clips. Secondary outcomes included closure time, the number of clips used, and adverse events.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical Effect of EDLS-clips in Endoscopic Full-thickness Resection
- ClinicalTrials.gov ID
- NCT07305038
- Acronym / sponsor ID
- End-D-F1
- Keywords
- endoscopic submucosal dissection, endoscopic full-thickness resection, endoscopic double-layer suturing method with metallic clips, submucosal tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Dec 2025 (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.
A retrospective analysis was conducted on patients who visited from March 2022 to May 2024 and underwent endoscopic full-thickness resection and double-layer suture with titanium clips under endoscopy. The basic clinical information, tumor characteristics, overall resection rate and postoperative complications of all patients were evaluated. To analyze the clinical effect of double-layer suture technique with titanium clips under endoscopy in clamping the wound surface after full-thickness endoscopic resection.
Detailed description
The clinical data of patients who underwent endoscopic double-layer suture with titanium clip after endoscopic full-thickness resection at the Endoscopy Center of the First Affiliated Hospital of China Medical University from March 2022 to May 2024 were collected. Indications for endoscopic treatment of SMT: ① For tumors suspected of having malignant potential through preoperative examination or confirmed by biopsy pathology, especially for those suspected of having GIST with a preoperative long diameter of ≤2cm, low risk of recurrence and metastasis, and possibly complete resection, endoscopic resection can be performed. For suspected low-risk GIST with a tumor long diameter greater than 2cm and preoperative assessment excluding lymph node or distant metastasis, under the premise of ensuring complete tumor resection, endoscopic resection can be considered to be carried out by experienced endoscopists in units with mature endoscopic treatment techniques. ② SMT with symptoms (such as bleeding, obstruction). ③ Patients who are suspected of being benign by preoperative examination or confirmed by pathology, but cannot be followed up regularly or whose tumors increase in a short period of time during the follow-up period, or who have a strong willingness for endoscopic treatment. When the tumor protrudes into the serosa or partially grows outside the cavity, or when it is found during the operation that the tumor is closely adhered to the serosa layer and cannot be separated, EFTR can be selected for endoscopic treatment. Complications related to SMT in endoscopic treatment: (1) Intraoperative bleeding: Bleeding that causes the patient's hemoglobin to drop by more than 20g/L. (2) Postoperative bleeding: Postoperative bleeding is manifested as hematemesis, melena or hematochezia, etc. In severe cases, there may be manifestations of hemorrhagic shock. It mostly occurs within one week after the operation, but it can also appear 2 to 4 weeks after the operation. (3) Delayed perforation: It is usually manifested as abdominal distension, aggravated abdominal pain, signs of peritonitis, fever, and imaging examination shows gas accumulation or an increase in gas accumulation compared to before. (4) Gas-related complications: including subcutaneous emphysema, mediastinal emphysema, pneumothorax and pneumoperitoneum, etc. (5) Digestive tract fistula: Digestive juices caused by endoscopic surgery flow into the thoracic or abdominal cavity through the leakage channel. From a patient's medical records collected in the patient's age, gender, lesion characteristics, endoscopic treatment and postoperative clinical course details and other information. The investigators define the position of the lesion on the short axis as the position of the lesion center. The closure time is defined as the period from the start (when the investigators insert the clamp into the visual field channel) to the end of closure (when the last clamp is released).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center from March 2022 to May 2024.
Key inclusion criteria (4 listed)
- Having a tumor located in the stomach and confirmed to originate from the muscularis propria on endoscopic ultrasonography (EUS);
- Having a tumor diameter >1 cm, which can be completely resected using endoscopic techniques, and with low risk of residue and recurrence;
- Preoperative assessment excluded those with lymph node or distant metastasis;
- Being able to tolerate tracheal intubation anesthesia, with no coagulation dysfunction or anticoagulant drugs stopped before EFTR.
Key exclusion criteria (3 listed)
- Patients who have been evaluated preoperatively and are considered to have lymph node or distant metastasis;
- who cannot tolerate general anesthesia with endotracheal intubation,
- who have not discontinued anticoagulant drugs before EFTR or have coagulation dysfunction.
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 |
|---|---|---|
| endoscopic double-layer suturing method with metallic clipsThis study comprises case series of 43 patients with gastric SMTs who underwent EDLS-clips after EFTR in our center. | Procedure or surgery | – |
Primary outcome
The complete closure rate of EDLS-clips
Time frame: Perioperative/Periprocedural
Successful closure refers to the full coverage of the mucosal defect by surrounding normal mucosa without any gaps.
2 secondary outcomes
Operative time
Time frame: Perioperative/Periprocedural
Suturing time
Time frame: Perioperative/Periprocedural
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 26 Dec 2025.
- Individual participant dataSharing planned: Yes. Investigators share the technical operation of this endoscopic double-layer suture method for closing the wounds after endoscopic full-thickness resection (EFTR) for gastric submucosal tumors (SMTs) using endoscopic double-layer suturing method using metal clips (EDLS-clips). This study included 43 patients with gastric SMTs who received EFTR and were treated with EDLS-clips from March 2022 to May 2024 at our center. The primary outcome was the complete closure rate by EDLS-clips. Secondary outcomes included closure time, the number of clips used, and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastric Submucosal Tumors and Endoscopic Full Thickness Resection (EFTR), run by First Hospital of China Medical University 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 4 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 26 Dec 2025. 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 complete closure rate of EDLS-clips (time frame: Perioperative/Periprocedural). 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 26 Dec 2025.