Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 28, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Locally Advanced Rectal Cancer (LARC)
Interventions
PROCEDURE

Endoscopic resection

Eligible patients will undergo endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID) after two to eight weeks of nCRT completion, depending on the used neo-adjuvant regimen. Procedures will be performed using the GIF EZ-1500 endoscope (Olympus America, Center Valley, PA, USA) and an electrosurgical unit (VIO 300 D; Erbe, Germany) to power the electrosurgical knife (1.5-mm DualKnife J, Olympus America). For mucosal incision, Endocut or Drycut mode will be used, while Precise, Swift or Spray Coagulation modes will support submucosal dissection and hemostasis. An initial submucosal lift will be created by Glycéol Gel injection. The ERBE Flushing Pump (Erbe, Germany) will supply further submucosal lift during dissection through foot pedal-controlled, pressurized injections of methylene blue and saline solution delivered via the DualKnife J's ceramic-tipped tubing.

BEHAVIORAL

Short interval restaging

"Close follow-up and endoscopic re-evaluation four to eight weeks after the initial evaluation\*.~\*Defined as the first endoscopic evaluation after completion of the neoadjuvant treatment"

PROCEDURE

Total mesorectal excision

This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).

Trial Locations (1)

1000

RECRUITING

CHU Saint Pierre, Brussels

All Listed Sponsors
lead

Centre Hospitalier Universitaire Saint Pierre

OTHER