First endoluminal system for transmural resection of colorectal tissue with a prototype full-thickness resection device in a porcine model.
BACKGROUND
Endoluminal transmural resection of colorectal lesions is a pivotal advance in endoscopic technology. A full-thickness resection device has been developed that functions through a combination of tissue grasping, stapling, and cutting under endoscopic guidance. This preclinical study evaluated the performance, safety, and effectiveness of the full-thickness resection device in a porcine model.


METHODS
The full-thickness resection device consists of an operative handle, flexible shaft, and a resection chamber head. Eight pigs were randomized to 2 survival groups (4 each) of 14 and 28 days. The mucosa was marked electrosurgically to delineate target areas in the distal colon. A gastroscope inserted through the channel of the full-thickness resection device was advanced together with the device to the target. Targeted tissue was pulled into the resection chamber with a forceps, staples were deployed, and the isolated specimen was resected with a cutting blade. Histologic and radiographic evaluations were performed.


RESULTS
All resections were transmural. Mean resected tissue diameter was 3.6 cm (1.4-5.2 cm). Mean procedure time was 30.2 (15) minutes. Minor mechanical problems required the use of replacement devices to complete 3 procedures. Resection sites were identified endoscopically and radiographically at sacrifice. In one animal, local adhesions were present. Histology evaluation disclosed resection line mucosal ulceration in 4 animals with fibroinflammatory changes consistent with healing.


CONCLUSIONS
The full-thickness resection device can be used for endoluminal transmural localized resection of colorectal tissue in an animal model.
Rajan
Elizabeth
E
Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota 55905, USA.
Gostout
Christopher J
CJ
Burgart
Lawrence J
LJ
Leontovich
Olga N
ON
Knipschiel
Mary A
MA
Herman
Lori J
LJ
Norton
Ian D
ID
D017130:Angioplasty / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D000818:Animals; D003106:Colon / Q000473:pathology / Q000601:surgery; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery*; D004195:Disease Models, Animal; D020776:Endoscopes, Gastrointestinal / Q000009:adverse effects; D016099:Endoscopy, Gastrointestinal / Q000009:adverse effects / Q000379:methods; D004867:Equipment Design; D005260:Female; D011897:Random Allocation; D012007:Rectum / Q000473:pathology / Q000601:surgery; D013552:Swine