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Endoscopic Surgical ProceduresNCT06779266

Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.

An observational study of Endoscopic Surgical Procedures, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. 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?
Suturing, Clipping and No closure
Type of treatment
Surgery or procedure
How many people
179 participants
Where
1 sitePoland
Study dates
1 Dec 2024to 10 Jan 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: The retrospective study included all individuals who underwent gastric ESD from June 2015 to June 2024 in a single high-volume center and had an Eastern Cooperative Oncology Group performance status score of 0 or 1. All included procedures were performed in a conventional manner. The resection site was either left open, clipped, or sutured.

Who may be able to join

  • underwent gastric ESD from June 2015 to June 2024
  • Eastern Cooperative Oncology Group performance status score of 0 or 1

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Jagiellonian University

    Krakow, Lesser Poland Voivodeship, 31061

Other trials in Poland

About this study

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding.

Read the detailed description

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding. The retrospective single-center study included individuals who underwent endoscopic submucosal dissection in the stomach. The resection site was either left open, clipped, or sutured. The study evaluated the overall procedure time (OPT), bleeding rate (BR), perforation rate, and length of hospital stay (HS). The assessment was conducted to compare the outcomes of "non-sutured vs. sutured" "no closure vs. closure" and "clipped vs. sutured" along with the propensity score matching analysis for reducing a potential selection bias.

Being tested
Suturing, Clipping, No closure
Keywords
Endoscopic Hand Suturing, Suturing Techniques, Endoscopic Submucosal Dissection, Gastrointestinal Bleeding, Endoscopic Closure Techniques
Medical subject headings
Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SuturingProcedure or surgery

    Also called Endoscopic Hand Suturing, Endoscopic Through-the-scope Suturing

    Endoscopic Suturing is a technique of the wound closure after advanced endoscopic third-space resections in 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.

  • ClippingProcedure or surgery

    Also called Endoscopic Through-the-scope Suturing

    Clipping is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the through-the-scope clips are delivered to the site through the working canal. The arms of the clip are properly put on the both sides of the defect and the clip is closed to seal the margins. The procedure may be repeated along the resection site for complete closure.

  • No closureProcedure or surgery

    The resection site after endoscopic submucosal dissection was left open, without additional closure.

Study groups in NCT06779266
Study groupRoleWhat they receive
No closureParticipants who underwent endoscopic submucosal dissection without additional closure of the resection site.
Receives: Procedure: No closure
SuturedParticipants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope suturing.
Receives: Procedure: Suturing
ClippedParticipants who underwent endoscopic submucosal dissection followed by closure of the resection site with through-the-scope clips.
Receives: Procedure: Clipping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delayed bleeding (DB) rate

    symptomatic bleeding occurring after the ESD procedure and within 28 days following the treatment. The symptoms included hematemesis, melena, and decrease in hemoglobin >2g/dL.

    Measured: 28 days

Secondary outcomes (3)

  1. Overall Procedure Time (OPT)

    Measured in minutes and based on the procedural protocol.

    Measured: procedural

  2. Perforation Rate

    Defined as post-procedural clinical signs of peritonitis with radiological signs of air in the peritoneal cavity.

    Measured: 28 days

  3. Length of Hospital Stay (HS)

    The time from the procedure to the discharge measured in days and based on the hospital database.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start1 Dec 2024
  3. Primary completion10 Jan 2025
  4. Study completion10 Jan 2025

Resources

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
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779266
Sponsor's protocol ID
2025-0101
Status last verified
Jan 2025
First submitted
12 Jan 2025
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
No
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

  • Jiang W, Cen L, Dong C, Zhu S, Shen Z, Li D. Prophylactic Clipping to Prevent Delayed Bleeding and Perforation After Endoscopic Submucosal Dissection and Endoscopic Mucosal Resection: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2022 Sep 1;56(8):643-653. doi: 10.1097/MCG.0000000000001721. Epub 2022 May 25.

    PubMed 35648969

  • Goto O, Morita Y, Takayama H, Hirasawa K, Sato C, Oyama T, Takahashi A, Abe S, Saito Y, Ono H, Kawata N, Otsuka T, Iwakiri K. Endoscopic hand suturing has the potential to reduce bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic agents: Multicenter phase II study. Dig Endosc. 2025 Mar;37(3):266-274. doi: 10.1111/den.14911. Epub 2024 Aug 28.

    PubMed 39193787

  • Jia Y, Zhai G, Wang E, Li P. Efficacy of local hemostatic agents after endoscopic submucosal dissection: a meta-analysis. Minim Invasive Ther Allied Technol. 2022 Oct;31(7):1017-1025. doi: 10.1080/13645706.2022.2111217. Epub 2022 Aug 24.

    PubMed 36000962

  • Libanio D, Pimentel-Nunes P, Bastiaansen B, Bisschops R, Bourke MJ, Deprez PH, Esposito G, Lemmers A, Leclercq P, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, Fuccio L, Bhandari P, Dinis-Ribeiro M. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2023 Apr;55(4):361-389. doi: 10.1055/a-2031-0874. Epub 2023 Mar 7.

    PubMed 36882090

  • Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

    PubMed 20189503

  • Orzeszko Z, Kasprzyk P, Zawada U, Marynczak K, Szura M, Spychalski M. Endoscopic Hand Suturing After Gastric Endoscopic Submucosal Dissection in Patients with Low to Intermediate Risk of Delayed Bleeding: A Retrospective Pilot Study. Dig Dis Sci. 2026 Aug 12. doi: 10.1007/s10620-026-10168-5. Online ahead of print.

    PubMed 42584762

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 2 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 16 Jan 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 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?

Delayed bleeding (DB) rate (time frame: 28 days). 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 NCT06779266, which also lists 6 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 16 Jan 2025.

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