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NCT07848360Toborzás még nem indult

Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors

Traction-assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors: A Prospective Randomized Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 30.

Rövid összefoglaló (regiszter, angolul)

This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment. Participants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device. The primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
66 (tervezett)
Első benyújtás
2026. szept. 18.
Kezdés
2026. okt. 1.
Elsődleges befejezés
2027. nov. 30.
Fő szponzor
Pusan National University Hospital
NCT-szám
NCT07848360

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 66
  • 2026. okt. 1. és az elsődleges befejezés (2027. nov. 30.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.
  • Use of antiplatelet or anticoagulant therapy that cannot be appropriately discontinued or adjusted before the procedure.
  • Altered anatomy of the rectum due to previous rectal surgery, radiotherapy, or other conditions that may interfere with standardization of the study procedure.

Más betegség

  • Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.
  • Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.
  • Severe cardiopulmonary disease, hepatic failure, renal failure, or other conditions considered to make sedation or endoscopic submucosal dissection unsafe.
  • Any other condition considered by the principal investigator or study investigator to make participation inappropriate.

Egyéb

  • Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.
  • Pregnancy or breastfeeding.
  • Inability to provide informed consent or impaired decision-making capacity.

Kiket keres a vizsgálat

  • Adults aged 19 years or older.
  • Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.
  • Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.
  • No suspected lymph node metastasis or distant metastasis based on abdominal/pelvic imaging or clinical assessment.
  • Lesions considered appropriate for endoscopic resection.
  • Ability to understand the purpose and procedures of the study and provide written informed consent.

Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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