Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.

Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.

Patients can understand and sign the informed consent.

Disqualifiers

Poor coagulation function(PT>15 seconds or APTT>45 seconds or INR>2.0)

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)

Indication of metastasis by preoperative imaging examinations

With more than or equal to 2 rectal neuroendocrine tumors

Trial design

Design model

Parallel

Treatments tested in this trial

  • modified double snare assisted endoscopic mucosal resection

    Procedure/Surgery

    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.

  • endoscopic submucosal dissection

    Procedure/Surgery

    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.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: ESDActive comparator 1 intervention
Group B: mDS-EMRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

complete resection

Rate of complete en bloc resection with microscopically negative margins.

Time frame
Day 30

Secondary outcomes

1

En bloc resection

Rate of complete resection as a single piece

Time frame
Day 30
2

operation success rate

Technical success was defined as the completion of procedure without abortion or conversion to other procedure

Time frame
Periprocedural
3

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
4

Postoperative hospital stay

Period from the day of operation to discharge

Time frame
through study completion, an average of 30 days

Other outcomes

1

Delayed perforation

Postoperative abdominal pain, along with pelvic infection. Free gas in the pelvic cavity can be observed by imaging examination.

Time frame
30 days after the operation
2

Delayed bleeding

Hemorrhage occurs withing 30 days after the procedure that requires endoscopic, radiological, or surgical intervention, or a blood transfusion may be required.

Time frame
30 days after the operation
3

Intraoperative bleeding

arterial bleeding or active oozing for more than 30 seconds during the operation, which required endoscopic, radiological, or surgical intervention.

Time frame
Intraoperative
4

Intraoperative perforation

Damage of muscular layer of rectal wall and a hole to extracavitary tissue can be observed by endoscopy.

Time frame
Intraoperative

Locations

This trial has no locations.

Sponsors and contacts

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