Advanced Endoscopic Resections for Rectal Neoplasms

Adoption of Advanced Endoscopic Resection Methods in the Treatment of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; Rectal Adenocarcinoma; Rectal Adenoma; Recurrent Rectal Adenocarcinoma; Rectal Neuroendocrine Neoplasm
• Intervention / Treatment: Procedure: Endoscopic intramuscular dissection; Procedure: Endoscopic submucosal dissection

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Zofia Orzeszko, MD; Phone Number: +123797145; Email: zofia.orzeszko@uj.edu.pl

Study Locations

• Poland
  • Krakow, Poland, 31061
    • Jagiellonian University in Krakow
    • Contact: Zofia Orzeszko, MD; Phone Number: +123797145; Email: zofia.orzeszko@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ESD; Patients who underwent endoscopic submucosal dissection for rectal neoplasm	Procedure: Endoscopic submucosal dissection; 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.
EID; Patients who underwent endoscopic intermuscular dissection for rectal neoplasm	Procedure: Endoscopic intramuscular dissection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraprocedural
Complete resection rate	The rate of lesions resected completely according to the pathological examination of the resected specimen.	Within 30 days after the procedure
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.	Intraprocedural
Length of hospital stay	The number of days from the day of the procedure (day 0) to the day of hospital discharge.	Within 30 days after the procedure
The need for additional treatment	The number of patients who required completion surgery or adjuvant (chemo)radiotherapy.	Within 12 months after the procedure

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopic Mucosal Resection
• Other Study ID Numbers: 1072.6120.2.63.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Permission for data sharing was not included in the bioethics committee approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No