An interventional study of ESD procedure and EMR-C procedure in Rectal Neuroendocrine Tumor, sponsored by Nanfang Hospital, Southern Medical University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's planned enrollment of 90 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
Procedure: ESD procedure
In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET
Procedure: EMR-C procedure
ESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding.
A transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding.
complete resection rate(R0 rate)
Complete resection was defined as negative horizontal and vertical margins of specimen.
Time frame: within 14 days after procedure
operating time
the time from endoscope in to endoscope out
Time frame: intraoperative
complications rate
Complications were defined as perforation or hemorrhage during or after operation.
Time frame: within 14 days after procedure
length of stay
calculated from the day of admission to day of discharge
Time frame: within 14 days after procedure
hospitalization cost
represent the hospital's costs of being hospitalized
Time frame: within 14 days after procedure
recurrence rate
a new rectal NET recurred confirmed by endoscopy and EUS
Time frame: one year after procedure
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University