Advanced Endoscopic Resections for Rectal Neoplasms

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Adoption of Advanced Endoscopic Resection Methods in the Treatment of Rectal Neoplasms

Conditions

Rectal Cancer, Rectal Adenocarcinoma, Rectal Adenoma, Rectal Neuroendocrine Neoplasm, Recurrent Rectal Adenocarcinoma

Being tested

Endoscopic submucosal dissection, Endoscopic intramuscular dissection

Medical subject headings

Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Endoscopic submucosal dissectionProcedure or 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 dissectionProcedure or 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: 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.

   Measured: During the procedure

3. Delayed bleeding rate

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

   Measured: Within 28 days after the procedure

4. Delayed perforation rate

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

   Measured: Within 14 days after the procedure

5. 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.

   Measured: Within 28 days following the procedure

6. 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.

   Measured: Within 30 days after the procedure

7. 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.

   Measured: Within 30 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Feb 2026
2. Study start1 Mar 2026 (estimated)
3. Primary completion30 Apr 2026 (estimated)
4. Study completion30 Apr 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Rectal CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.