Rectal Neuroendocrine Tumors
Conditions
Keywords
Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection, rectal neuroendocrine tumor
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREmodified double snare assisted endoscopic mucosal resection
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.
PROCEDUREendoscopic submucosal dissection
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Typical rectal neuroendocrine tumors by endoscopy (within 15cm from the anal verge, yellowish subepithelial elevation with a smooth surface, and dilated blood vessels in some areas). 2. The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment. 3. Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment. 4. Patients can understand and sign the informed consent.
Exclusion criteria
1. Poor coagulation function(PT\>15 seconds or APTT\>45 seconds or INR\>2.0) 2. With severe cardiovascular or cerebrovascular diseases and cannot tolerate operation( with a history of stroke or myocardial infarction within the past month or with severe heart failure and cardiac function grade III) 3. Indication of metastasis by preoperative imaging examinations 4. With more than or equal to 2 rectal neuroendocrine tumors 5. With other complications that are not suitable for this study by multidisciplinary team assesment 6. Cases of recurrence after operation for neuroendocrine tumors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete resection | Day 30 | Rate of complete en bloc resection with microscopically negative margins. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection | Day 30 | Rate of complete resection as a single piece |
| operation success rate | Periprocedural | Technical success was defined as the completion of procedure without abortion or conversion to other procedure |
| operation time | Periprocedural | 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. |
| Postoperative hospital stay | through study completion, an average of 30 days | Period from the day of operation to discharge |
| operation-related expenses | through study completion, an average of 30 days | Consumables cost of mDS-EMR and ESD |
| Average hospitalization expenses | through study completion, an average of 30 days | All the expenses during the hospitalization period |
Outcome results
None listed