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Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

31. mai 2026 oppdatert av: Dong Yang, Jilin University

Retrospective Comparative Study of Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

The aim is to compare the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EPMR group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The investigators compared the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EID group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies. Through this comparative analysis, The investigators would identify the optimal endoscopic technique for treating rectal neuroendocrine tumors.

Studietype

Intervensjonell

Registrering (Antatt)

483

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Changchun, Kina, 130021
        • Aktiv, ikke rekrutterende
        • The First Hospital of Jilin University
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Rekruttering
        • The First Hospital of Jilin University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients undergoing endoscopic treatment for rectal neuroendocrine neoplasms.
  • Lesion diameter less than 2 cm.
  • Preoperative auxiliary examinations indicating no peripheral lymph node or distant metastasis.
  • Endoscopic surgical approach limited to ESD or EPMR.

Exclusion Criteria:

  • Use of non-ESD or non-EPMR endoscopic techniques, such as ligation-assisted resection or Endoscopic Mucosal Resection (EMR).
  • Presence of other conditions deemed by the investigator to be unsuitable for participation in this study.
  • Patient or family refusal to participate.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: ESD group
The ESD group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic submucosal dissection (ESD).
Fremgangsmåte: Endoscopic Submucosal Dissection (ESD)
ESD: A solution is injected beneath the mucosa to create a submucosal cushion, followed by the use of specialized electrosurgical knives to dissect directly within the submucosal layer, thereby achieving en bloc resection of the tumor.
Eksperimentell: EID group
The EPMR group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic partial muscle resection ( EPMR).
Fremgangsmåte: endoscopic intermuscular dissection (EID)
EID：Endoscopic Intermuscular Dissection (EID) is an ultra-minimally invasive technique derived from conventional Endoscopic Submucosal Dissection (ESD). Its core principle is not merely to dissect within the submucosal layer, but to "deepen" the dissection plane into the muscularis propria of the rectal wall. Specifically, the surgeon utilizes the natural anatomical plane between the inner circular muscle and the outer longitudinal muscle layers for precise dissection. This procedure involves resecting part of the affected inner circular muscle while preserving the integrity of the outer longitudinal muscle layer.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
the positive margin rate
Tidsramme: One week after the endoscopic treatment
A positive margin indicates that cancer cells extend to the edge of the removed specimen, suggesting that residual tumor may remain in situ. The positive margin rate is calculated as the number of cases with positive margins divided by the total number of resected cases, expressed as a percentage. It serves as a critical quality indicator for the completeness of tumor removal.
One week after the endoscopic treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of rectal neuroendocrine neoplasm lesions.
Tidsramme: One week after the endoscopic treatment
The number of rectal neuroendocrine neoplasm lesions per case.
One week after the endoscopic treatment

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum lesion diameter.
Tidsramme: one week after the endoscopic treatment
The longest diameter of each lesion was measured endoscopically and recorded in centimeters.
one week after the endoscopic treatment
Operation time per single lesion.
Tidsramme: One week after the endoscopic dissection
The procedure time for each lesion was measured from the start of dissection to completion, expressed in minutes.
One week after the endoscopic dissection
Complications (including bleeding and perforation).
Tidsramme: One week after the endoscopic dissection
All complications were recorded including bleeding and perforation.
One week after the endoscopic dissection

Samarbeidspartnere og etterforskere

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Sponsor

Jilin University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 130023

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Nei

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