Advanced Endoscopic Resections for Rectal Neoplasms

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJagiellonian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with rectal neoplasms treated by advanced endoscopic resection

Disqualifiers

hybrid resection performed

full-thickness resection performed

essential procedural or outcome data were unavailable

Trial population

Patients with rectal neoplasms treated with advanced endoscopic resection in a tertiary center.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Endoscopic submucosal dissection

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: ESD1 intervention
Group B: EID1 intervention

Trial outcomes

Primary outcomes

1

Major intraprocedural bleeding rate

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

Time frame
During the procedure
2

Intraprocedural perforation rate

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.

Time frame
During the procedure
3

Delayed bleeding rate

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

Time frame
Within 28 days after the procedure
4

Delayed perforation rate

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

Time frame
Within 14 days after the procedure

Secondary outcomes

1

En bloc resection rate

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

Time frame
Intraprocedural
2

Complete resection rate

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

Time frame
Within 30 days after the procedure
3

Procedure time

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.

Time frame
Intraprocedural
4

Length of hospital stay

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

Time frame
Within 30 days after the procedure

Other outcomes

Sponsors and contacts

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