The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.
A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
A polypectomy snare (resection snare) was placed outside of the endoscope. After approaching the lesion, a second polypectomy snare (capture snare) was inserted through the biopsy channel of the endoscope to grasp and lift the lesion. The snare preloaded outside of the endoscope was released, passed through the capture snare and positioned below the capture snare to grasp the base of the lesion. Once the lesion was securely grasped, it was resected by resection snare to achieve en bloc resection. The wounds were closed by clips.
The procedure includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife (such as Dual knife, Golden knife or Kunpeng knife, etc.) , hemostasis and sealing of the wound. Traction is allowed during the operation.
complete resection
Rate of complete en bloc resection with microscopically negative margins.
Time frame: Day 30
En bloc resection
Rate of complete resection as a single piece
Time frame: Day 30
operation success rate
Technical success was defined as the completion of procedure without abortion or conversion to other procedure
Time frame: Periprocedural
operation time
Operation time of ESD refers to the period from marking to completely removing the lesion, including submucosal injection, circumferential incision, submucosal dissection, additional submucosal injection and hemostasis during the operation and closure of the wound. Operation time of mDS-EMR refers to the period from the placing of the external snare to completely removing the lesion, hemostasis and closure of the wound.
Time frame: Periprocedural
Postoperative hospital stay
Period from the day of operation to discharge
Time frame: through study completion, an average of 30 days
operation-related expenses
Consumables cost of mDS-EMR and ESD
Time frame: through study completion, an average of 30 days
Average hospitalization expenses
All the expenses during the hospitalization period
Time frame: through study completion, an average of 30 days
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