Advanced Endoscopic Resections for Rectal Neoplasms

Sponsor
Jagiellonian University
Study ID
NCT07410767
Status
Not Yet Recruiting

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Conditions

  • Rectal Adenocarcinoma
  • Rectal Adenoma
  • Rectal Cancer
  • Rectal Neuroendocrine Neoplasm
  • Recurrent Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic submucosal dissection — PROCEDURE
    Endoscopic submucosal dissection is an advanced endoscopic technique used to remove rectal tumors in one piece through the endoscope. A circumferential incision is then made in the mucosa, followed by careful dissection within the submucosal layer until the lesion is completely removed. This technique enables precise pathological assessment of tumor margins and depth of invasion and is typically used for lesions suspected to have superficial submucosal invasion without clear evidence of lymph node involvement. The procedure is performed using standard therapeutic endoscopic equipment and electrosurgical devices.
  • Endoscopic intramuscular dissection — PROCEDURE
    Endoscopic intermuscular dissection is an advanced endoscopic resection technique designed for rectal tumors with suspected deeper submucosal invasion. Following mucosal incision, the dissection is intentionally performed in the plane between the inner circular and outer longitudinal muscle layers of the rectal wall. This allows deeper en bloc tumor removal compared with conventional endoscopic submucosal dissection. The goal of this technique is to achieve complete resection while potentially avoiding radical surgery in selected patients. The procedure is performed endoscopically using specialized dissection knives and electrosurgical systems and requires advanced operator expertise.

Study Details

This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer. Rectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established. This multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches. The results of this study may help guide treatment selection and improve care for people with rectal cancer.

Key Dates

First listed
Feb 13, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: ESD
    Patients who underwent endoscopic submucosal dissection for rectal neoplasm
  • Arm: EID
    Patients who underwent endoscopic intermuscular dissection for rectal neoplasm

Primary Outcome Measure

Major intraprocedural bleeding rate [ Time Frame: During the procedure ]

Central Contacts

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