Advanced Endoscopic Resections for Rectal Neoplasms

NCT07410767 | Not Yet Recruiting

• 1 other identifier: 1072.6120.2.63.2026
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenoma; Rectal Neuroendocrine Neoplasm; Recurrent Rectal Adenocarcinoma; Rectal Cancer; Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (7)

• 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

  During the procedure

• 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.

  During the procedure

• Delayed bleeding rate

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

  Within 28 days after the procedure

• Delayed perforation rate

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

  Within 14 days after the procedure

• Post-coagulation syndrome rate

  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.

  Within 28 days following the procedure

• The need for emergency interventions

  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.

  Within 30 days after the procedure

• Procedure-related mortality rate

  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.

  Within 30 days after the procedure

Secondary Outcomes (5)

• En bloc resection rate

  Intraprocedural

• Complete resection rate

  Within 30 days after the procedure

• Procedure time

  Intraprocedural

• Length of hospital stay

  Within 30 days after the procedure

• The need for additional treatment

  Within 12 months after the procedure

Study Arms (2)

ESD

Patients who underwent endoscopic submucosal dissection for rectal neoplasm

Procedure: Endoscopic submucosal dissection

EID

Patients who underwent endoscopic intermuscular dissection for rectal neoplasm

Procedure: Endoscopic intramuscular dissection

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.

ESD

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.

EID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with rectal neoplasms treated by advanced endoscopic resection

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University in Krakow

Krakow, 31061, Poland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Zofia Orzeszko, MD

CONTACT

+123797145; zofia.orzeszko@uj.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant General Surgeon

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)