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NCT Number: NCT07410767

Advanced Endoscopic Resections for Rectal Neoplasms

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Adenocarcinoma Rectal Adenoma Rectal Diseases Rectal Neoplasms Rectal Neuroendocrine Neoplasm Recurrent Rectal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with rectal neoplasms treated by advanced endoscopic resection

Exclusion criteria

  • hybrid resection performed
  • full-thickness resection performed
  • essential procedural or outcome data were unavailable

Treatment and study plan

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.

Primary outcomes

  1. Major intraprocedural bleeding rate

    Time frame: During the procedure

    Bleeding occurring during the procedure that required advanced endoscopic hemostatic interventions beyond standard coagulation with the tip of the knife of coagulation forceps, resulted in hemodynamic instability, caused a significant prolongation of the procedure over 15 minutes (based on video), or led to procedure interruption or conversion

  2. Intraprocedural perforation rate

    Time frame: During the procedure

    Full-thickness defect of the gastrointestinal wall identified during the procedure, evidenced by direct visualization of extraluminal structures (mesorectum or peritoneal cavity), or confirmed by the presence of free air on imaging performed immediately after the procedure.

  3. Delayed bleeding rate

    Time frame: Within 28 days after the procedure

    Symptomatic bleeding including hematemesis, melena, or a hemoglobin decrease of more than 2 g/dL.

  4. Delayed perforation rate

    Time frame: Within 14 days after the procedure

    Clinical signs of peritonitis accompanied by radiological evidence of free intraperitoneal air.

  5. Post-coagulation syndrome rate

    Time frame: Within 28 days following the procedure

    The occurrence of localized abdominal pain or peritoneal irritation signs after EID, accompanied by inflammatory response (elevated white blood cell count or C-reactive protein), in the absence of radiological or endoscopic evidence of perforation.

  6. The need for emergency interventions

    Time frame: Within 30 days after the procedure

    Any unplanned therapeutic intervention related to the index procedure during hospitalization or follow-up, including repeat endoscopy, endoscopic or radiological intervention, blood transfusion, or surgical treatment. Planned surveillance procedures were not considered additional interventions.

  7. Procedure-related mortality rate

    Time frame: Within 30 days after the procedure

    Number of deaths occurring within 30 days of the index procedure that was directly attributable to the procedure or to procedure-related complications. Deaths unrelated to the procedure were reported but not considered procedure-related mortality.

Secondary outcomes

  1. En bloc resection rate

    Time frame: Intraprocedural

    The rate of lesions removed in a single specimen, enabling accurate macroscopic and histological assessment as reported by an endoscopist in a procedure protocol.

  2. Complete resection rate

    Time frame: Within 30 days after the procedure

    The rate of lesions resected completely according to the pathological examination of the resected specimen.

  3. Procedure time

    Time frame: Intraprocedural

    Procedure time was evaluated on the procedure video and defined as the interval from the insertion of the scope to its final withdrawal measured in minutes; anesthesia-related time was not included.

  4. Length of hospital stay

    Time frame: Within 30 days after the procedure

    The number of days from the day of the procedure (day 0) to the day of hospital discharge.

  5. The need for additional treatment

    Time frame: Within 12 months after the procedure

    The number of patients who required completion surgery or adjuvant (chemo)radiotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Zofia Orzeszko, MD

CONTACT

[email protected]

+123797145

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Adoption of Advanced Endoscopic Resection Methods in the Treatment of Rectal Neoplasms

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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