Endoscopic Surgical ProceduresNCT06622746
Endoscopic Hand Suturing After Advanced Endoscopic Resections.
An observational study of Endoscopic Surgical Procedures, run by Jagiellonian University at 1 site in Poland.
Trial summary
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Surgical Procedures
- What is being tested?
- Endoscopic Hand Suturing
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2024to 30 Aug 2024
- 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 retrospective single-center study included all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024. Procedures were conducted both in the upper and lower GI tract and included endoscopic intermuscular dissection (EID), endoscopic mucosal resection (EMR), ESD, EFTR, POEM, and STER. The EHS was performed to close a GI wall defect (after EMR, ESD, or EID) or the linear entry mucosal incision (after POEM or STER). The indications for additional suturing were high risk of bleeding following ESD in upper GI (based on patients' history of anticoagulant therapy and advanced age), closing the deep wall defect after EID in the rectum to improve recovery, closing the full-thickness defect after EFTR in cases of submucosal lesions, and concurrent treatment for perforation during ESD.
Who may be able to join
- all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Hand Suturing After Advanced Endoscopic Resections - Early Outcomes of 31 Cases in Upper and Lower GI Tract.
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes.
Read the detailed description
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes. The retrospective single-center study included individuals that underwent advanced endoscopic procedures in upper and lower GI tract followed by EHS. Defined features (suturing time, suturing speed) and outcomes (postprocedural bleeding, abdominal pain) were assessed. Thirty-one patients were included in the analysis.
- Conditions
- Endoscopic Surgical Procedures
- Being tested
- Endoscopic Hand Suturing
- Keywords
- Endoscopic Hand Suturing, Suturing Techniques, Endoscopic Submucosal Dissection, Submucosal Tunneling Endoscopic Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Hand SuturingProcedure or surgery
Endoscopic Hand Suturing is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the needle is held on the opposite side from the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated from the middle of the wound to create a symmetrical structure.
| Study group | Role | What they receive |
|---|---|---|
| EHS | All individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024 Receives: Procedure: Endoscopic Hand Suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing time
The time between delivering and retrieving the needle, in minutes.
Measured: From 1st of March 2023 to 30th of July 2024.
Suturing speed
Calculated by dividing the longitudinal length of the defect in millimeters by the suturing time in minutes.
Measured: From 1st of March 2023 to 30th of July 2024.
Secondary outcomes (1)
Postprocedural bleeding rate
The prevalence of the symptoms of gastrointestinal bleeding.
Measured: From 1st of March 2023 to 30th of July 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Apr 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Surgical ProceduresStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zofia Orzeszko, Jagiellonian University
- Investigators
- Michal Spychalski, PhD, Study chair, Center of Bowel TreatmentZofia Orzeszko, PhD, Principal investigator, Jagiellonian University in Cracow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622746
- Sponsor's protocol ID
- 2024.000.586
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to share the encrypted data with other investigators after appropriate application and approval of the study chair.
Publications
Goto O, Oyama T, Ono H, Takahashi A, Fujishiro M, Saito Y, Abe S, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand-suturing is feasible, safe, and may reduce bleeding risk after gastric endoscopic submucosal dissection: a multicenter pilot study (with video). Gastrointest Endosc. 2020 May;91(5):1195-1202. doi: 10.1016/j.gie.2019.12.046. Epub 2020 Jan 7.
PubMed 31923410Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Takatori Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy. Dig Endosc. 2022 Jan;34(1):123-132. doi: 10.1111/den.14045. Epub 2021 Jun 22.
PubMed 34021512Uozumi T, Abe S, Mizuguchi Y, Sekiguchi M, Toyoshima N, Takamaru H, Yamada M, Kobayashi N, Sadachi R, Ito S, Takada K, Kishida Y, Imai K, Hotta K, Ono H, Saito Y. Endoscopic hand suturing using a modified through-the-scope needle holder for mucosal closure after colorectal endoscopic submucosal dissection: Prospective multicenter study (with video). Dig Endosc. 2024 Nov;36(11):1245-1252. doi: 10.1111/den.14808. Epub 2024 May 22.
PubMed 38775419Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic suturing promotes healing of mucosal defects after gastric endoscopic submucosal dissection: endoscopic and histologic analyses in in vivo porcine models (with video). Gastrointest Endosc. 2020 May;91(5):1172-1182. doi: 10.1016/j.gie.2019.12.032. Epub 2020 Jan 3.
PubMed 31904381Abe S, Saito Y, Tanaka Y, Ego M, Yanagisawa F, Kawashima K, Takamaru H, Sekiguchi M, Yamada M, Sakamoto T, Matsuda T, Goto O, Yahagi N. A novel endoscopic hand-suturing technique for defect closure after colorectal endoscopic submucosal dissection: a pilot study. Endoscopy. 2020 Sep;52(9):780-785. doi: 10.1055/a-1120-8533. Epub 2020 Mar 23.
PubMed 32207119
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Hand Suturing After Advanced Endoscopic Resections - Early Outcomes of 31 Cases in Upper and Lower GI Tract.
- ClinicalTrials.gov ID
- NCT06622746
- Acronym / sponsor ID
- 2024.000.586
- Conditions
- Endoscopic Surgical Procedures
- Keywords
- Endoscopic Hand Suturing, Suturing Techniques, Endoscopic Submucosal Dissection, Submucosal Tunneling Endoscopic Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 2 Oct 2024 (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.
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes.
Detailed description
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes. The retrospective single-center study included individuals that underwent advanced endoscopic procedures in upper and lower GI tract followed by EHS. Defined features (suturing time, suturing speed) and outcomes (postprocedural bleeding, abdominal pain) were assessed. Thirty-one patients were included in the analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EHS | – | Procedure: Endoscopic Hand SuturingAll individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective single-center study included all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024. Procedures were conducted both in the upper and lower GI tract and included endoscopic intermuscular dissection (EID), endoscopic mucosal resection (EMR), ESD, EFTR, POEM, and STER. The EHS was performed to close a GI wall defect (after EMR, ESD, or EID) or the linear entry mucosal incision (after POEM or STER). The indications for additional suturing were high risk of bleeding following ESD in upper GI (based on patients' history of anticoagulant therapy and advanced age), closing the deep wall defect after EID in the rectum to improve recovery, closing the full-thickness defect after EFTR in cases of submucosal lesions, and concurrent treatment for perforation during ESD.
Key inclusion criteria (1 listed)
- all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024.
Key exclusion criteria (1 listed)
- none
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 Hand SuturingEndoscopic Hand Suturing is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the needle is held on the opposite side from the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated from the middle of the wound to create a symmetrical structure. | Procedure or surgery | EHS |
Primary outcome
Suturing time
Time frame: From 1st of March 2023 to 30th of July 2024.
The time between delivering and retrieving the needle, in minutes.
Suturing speed
Time frame: From 1st of March 2023 to 30th of July 2024.
Calculated by dividing the longitudinal length of the defect in millimeters by the suturing time in minutes.
1 secondary outcome
Postprocedural bleeding rate
Time frame: From 1st of March 2023 to 30th of July 2024.
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 Oct 2024.
- Background: PubMed 31923410Goto O, Oyama T, Ono H, Takahashi A, Fujishiro M, Saito Y, Abe S, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand-suturing is feasible, safe, and may reduce bleeding risk after gastric endoscopic submucosal dissection: a multicenter pilot study (with video). Gastrointest Endosc. 2020 May;91(5):1195-1202. doi: 10.1016/j.gie.2019.12.046. Epub 2020 Jan 7.
- Background: PubMed 34021512Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Takatori Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy. Dig Endosc. 2022 Jan;34(1):123-132. doi: 10.1111/den.14045. Epub 2021 Jun 22.
- Background: PubMed 38775419Uozumi T, Abe S, Mizuguchi Y, Sekiguchi M, Toyoshima N, Takamaru H, Yamada M, Kobayashi N, Sadachi R, Ito S, Takada K, Kishida Y, Imai K, Hotta K, Ono H, Saito Y. Endoscopic hand suturing using a modified through-the-scope needle holder for mucosal closure after colorectal endoscopic submucosal dissection: Prospective multicenter study (with video). Dig Endosc. 2024 Nov;36(11):1245-1252. doi: 10.1111/den.14808. Epub 2024 May 22.
- Background: PubMed 31904381Akimoto T, Goto O, Sasaki M, Mizutani M, Tsutsumi K, Kiguchi Y, Nakayama A, Kato M, Fujimoto A, Ochiai Y, Maehata T, Kaise M, Iwakiri K, Yahagi N. Endoscopic suturing promotes healing of mucosal defects after gastric endoscopic submucosal dissection: endoscopic and histologic analyses in in vivo porcine models (with video). Gastrointest Endosc. 2020 May;91(5):1172-1182. doi: 10.1016/j.gie.2019.12.032. Epub 2020 Jan 3.
- Background: PubMed 32207119Abe S, Saito Y, Tanaka Y, Ego M, Yanagisawa F, Kawashima K, Takamaru H, Sekiguchi M, Yamada M, Sakamoto T, Matsuda T, Goto O, Yahagi N. A novel endoscopic hand-suturing technique for defect closure after colorectal endoscopic submucosal dissection: a pilot study. Endoscopy. 2020 Sep;52(9):780-785. doi: 10.1055/a-1120-8533. Epub 2020 Mar 23.
- Individual participant dataSharing planned: Undecided. We intend to share the encrypted data with other investigators after appropriate application and approval of the study chair.
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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.
Michal Spychalski, PhD study chair
Center of Bowel Treatment
Zofia Orzeszko, PhD principal investigator
Jagiellonian University in Cracow
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 Endoscopic Surgical Procedures, run by Jagiellonian University at 1 site in Poland.
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 1 inclusion and 1 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 Oct 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 Poland. 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?
Suturing time (time frame: From 1st of March 2023 to 30th of July 2024.). The study lists 2 primary outcomes in all. 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 NCT06622746, which also lists 5 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 2 Oct 2024.