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Looks like I might participate in the TRIASSIC-study to help compare TAMIS versus ESD for resection of non-pedunculated rectal lesions

Posted by jpluimers on 2022/05/06

As a follow up of Some links on removing colon tissue with Endoscopic Full Thickness Resection (EFTR), it looks like I might participate in the TRIASSIC-study to help compare TAMIS versus ESD for resection of non-pedunculated rectal lesions.

The reason I document is my earlier Tweet: [Wayback/Archive] Jeroen Wiert Pluimers on Twitter: “Meh result of the colonoscopy: – 2 polyps of ~1cm size removed – 1 polyp of ~2.5cm could not be removed now: it is in an odd place (grows over the LAR-resection seam) and needs team-discussion on what to do in a future procedure (hopefully colonoscopy, maybe larpscopy) 1/”

So I archived most links from searching for EDS and TAMIS (further below) plus the whole content of the [Wayback/Archive] TRIASSIC-study:

A multicentre, randomised controlled trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions.

Links (English and Dutch)

English

  • [Wayback/Archive] TRIASSIC-study

    A multicentre, randomised controlled trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions.

  • [Wayback/Archive] About the study
    Rationale
    Colorectal cancer (CRC) is the second most prevalent cancer in the Netherlands, with 15,000 new cases per year and 5000 colorectal cancer related deaths. The Dutch National Colorectal Cancer screening program began in 2014 and is expected to save 1400 lives per year in the short term through early diagnosis and treatment of cancer. In the last few years two new highly promising innovative approaches have become available for minimally invasive en bloc resection of large nonpedunculated rectal lesions. One is a new surgical technique called transanal minimally invasive surgery (TAMIS) and the other is a new endoscopic technique called endoscopic submucosal dissection (ESD). Although both techniques are standard of care in the Netherlands, a direct randomised comparison between TAMIS and ESD is lacking. Therefore, the choice for either of both therapies remains operator-dependent instead of evidence-based.Study Objectives
    De Triassic study is to compare TAMIS with ESD with regard to:Primary Objective
    Cumulative recurrence rate at follow-up rectoscopy after 6 and 12 months, either as visible residual disease confirmed at histology as neoplastic after removal or, if no visible residual disease is present, from biopsies of the scar.Secundary objectives
    • En bloc resection rate, defined as macroscopic removal of the lesion in a single piece.
    • Radical (R0-) resection rate at histology for benign lesions
    • Radical (R0-) resection rate  at histology for invasive lesions.
    • Perceived burden and quality of life among patients
    • Cost effectiveness at 12 months
    • The need for additional trans abdominal surgery
    • Complication rate
    • To compare the long-term recurrence rate at follow-up rectoscopy at 12 months either as visible and subsequently resected recurrent/residual disease or, if not present, from biopsies of the scar.

    Inclusion criteria
    • Non-pedunculated polyp >2cm in the rectum where the bulk of the lesion is below 15cm from the anal verge found at colonoscopy
    • ≥18 years old
    • Written informed consent

    Exclusion criteria
    • Features of advanced disease or deep-submucosal invasion at optical endoscopic evaluation.*
    • Features of advanced disease on cross-sectional imaging.*
    • Prior endoscopic resection attempt
    • The risk exceeds the benefit of endoscopic treatment, such as patients with an extremely poor general condition or a very short life expectancy
    * Where there is discordance in the results, the optical endoscopic evaluation will be given the most weight and the case discussed by an expert panel of four study participants

    Follow-up
    Endoscopic
    All patients must be receive follow-up by rectoscopy at 6 and 12 months after initial procedure
    If recurrence is found at the 12-month colonoscopy this will be resected and further surveillance colonoscopie planned 6 months later (18 months after initial procedure)
    • If there is no visible residual disease, please take 3 biopsies from the scar
    • Note that there are forms to fill in after the follow-up rectoscopy in Castor

    Questionnaires
    Questionnaires will be directly sent from the LUMC to patients at baseline, after 4 days and 4 weeks after ESD/TAMIS and after the follow-up rectoscopy at 6 and 12 months.

    Important notes
    • Only endoscopists that have performed >25 ESD procedures are allowed to participate
    • Only surgeons that have performed >25 TAMIS procedures are allowed to participate
    • If there is no visible residual disease at follow-up, please take 3 biopsies from the scar
    • The resected specimen needs to be correctly pinned out

  • [Wayback/Archive] Registration
  • [Wayback/Archive] Documents (note that “Protocol versie 1.1” does not function)

    Protocol
    Protocol versie 1.1

    Patient information
    Only available in Dutch.

    Datamanagement
    See the Castor log-in page for randomisation and data entry.

  • [Wayback/Archive] Participation

    The TRIASSIC study was approved by the ethics committee (MREC) of the LUMC in December 2018. The TRIASSIC study is now open for inclusion.

  • [Wayback/Archive] (Serious) Adverse events
    All events leading to:
    • 10 days (Additional) admission and/or
    • 4 (EH) blood transfusions and/or
    • Angiographic or surgical intervention and/or
    • ICU admission and/or
    • DeathAdverse events related to the procedure: Intraprocedural perforation, intraprocedural bleeding, postprocedural bleeding (Within 30 days) or postprocedural serositis (Within 30 days)SAEs should be registered in Castor within 24 hours
  • [Wayback/Archive] Contact
  • [Wayback/Archive] Error 404 (Randomisation)
  • [Wayback/Archive] Castor EDC – Login

Dutch

Subsidie: [Wayback/Archive] Subsidie voor onderzoek naar beste techniek verwijderen endeldarmpoliep | LUMC

18 juli 2018• PERSBERICHT

Onderzoekers van het Leids Universitair Medisch Centrum (LUMC) gaan uitzoeken wat de beste techniek is om verdachte grote poliepen uit de endeldarm te verwijderen. Ze krijgen daarvoor ruim 500.000 euro subsidie uit het Doelmatigheidsprogramma van ZonMw.
De onderzoekers gaan twee methoden vergelijken om een poliep in de endeldarm in zijn geheel te verwijderen. De poliep moet worden verwijderd, zodat onder de microscoop kan worden gekeken of het wel of geen endeldarmkanker is.
“We weten dat de technieken die wij vergelijken beter zijn dan het snelle weghalen van de poliep in kleine stukjes. Dat laatste verhoogt namelijk de kans op een aanvullende operatie via de buik om de hele endeldarm te verwijderen. Zo’n operatie is in de endeldarm ingrijpender en gevaarlijker dan elders in de darm, met kans op een blijvend stoma en seksuele problemen zoals impotentie”, aldus onderzoeksleider en hoogleraar Maag-, Darm, Leverziekten James Hardwick. Maar welke van de twee alternatieve methoden om de poliep in een stuk te verwijderen de beste is, is nog nooit onderzocht.

Roesje versus narcose

De ene methode is endoscopische submucosale dissectie (ESD), waarbij de maag-darm-leverarts een flexibele slang gebruikt om een verdachte poliep in één stuk te verwijderen. Tijdens de ingreep in het endoscopiecentrum krijgt de patiënt een roesje. De tweede methode heet transanale minimaal-invasieve chirurgische techniek (TAMIS),  endoscopische submucosale dissectie (ESD) versus transanale minimaal-invasieve chirurgische techniek (TAMIS).waarbij een chirurg op de verdachte poliep op de operatiekamer in zijn geheel via de anus verwijdert. Tijdens deze ingreep gaat de patiënt onder volledige narcose.
In hun vergelijking kijken de onderzoekers naar het aantal succesvolle verwijderingen van poliepen, naar het aantal patiënten bij wie de poliep/kanker terugkeert na zes maanden, naar complicaties, naar de beleving van de patiënt en naar de kosten.

Minder complicaties

“We verwachten dat de methode met de flexibele slang zorgt voor minder terugkeer van de poliep, minder complicaties oplevert en minder duur is dan de operatie”, aldus Hardwick. De onderzoekers verwachten de eerste resultaten over vier jaar.

ESD and TAMIS

Queries

–jeroen


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