LCD L38551: Transanal Endoscopic Surgery (TES)

Transanal endoscopic surgery (TES) may be considered medically necessary for treatment of rectal adenomas, including recurrent adenomas that cannot be removed using other means of local excision.

TES may be considered medically necessary for treatment of clinical stage T1 rectal adenocarcinomas that cannot be removed using other means of local excision and that meet all of the following criteria:

• Located within 8 cm of the anal verge

• Less than 3 cm in size

• Well-to-moderately differentiated (G1 or G2) by biopsy

• Without lymphadenopathy

• Less than 30% of the circumference of the rectum

TES may be considered medically necessary for treatment of rectal carcinoid tumors that cannot be removed using other means of local excision and that meet all of the following criteria:

• Located within 8 cm of the anal verge

• Less than 2 cm in size

• No radiologic evidence of metastasis

• Less than 30% of the circumference of the rectum

TES is considered investigational for treatment of rectal tumors that do not meet the criteria noted.

Credentialing and Accreditation Standards

Optimal outcomes of TES procedures depend on the knowledge, skill and experience of the provider. Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

FDA Indications

Transanal Endoscopic microsurgery (TEM) combination system and instrument set. 510K Summary: K000180.

GelPOINT Path Transanal Access Platform. 510K Summary: K133393 .

GelPOINT Path Transanal Access Platform. 510K Summary: K171701 .

TES is a minimally invasive approach to local excision of rectal lesions. It has been used in benign conditions such as large rectal polyps (that cannot be removed through a colonoscope), retrorectal masses, rectal strictures, rectal fistulae, pelvic abscesses, and in malignant conditions (e.g., malignant polyps). Use of transanal endoscopic microsurgery (TEMS) for resection of rectal cancers is more controversial. TEMS can avoid morbidity and mortality associated with major rectal surgery, including the fecal incontinence related to stretching of the anal sphincter, and can be performed under general or regional anesthesia.

The TEMS system has a specialized magnifying rectoscope with ports for insufflation, instrumentation, and irrigation. This procedure has been available for over 20 years in Europe but has not been widely used in the United States. Two reasons for this slow adoption are the steep learning curve for the procedure and the limited indications. For example, most rectal polyps can be removed endoscopically, and many rectal cancers need a wide excision and are thus not amenable to local resection.

Transanal minimally invasive surgery (TAMIS) was introduced in 2010 and utilizes a single incision laparoscopic surgery port. The advantage of this technique is lower cost and ease of patient positioning. TAMIS appears to require less training and skill for surgeons already proficient in single incision laparoscopic surgery due to its utilization of the same platform and instruments.

The most common treatment for rectal cancer is surgery; the technique chosen will depend on several factors. The size and location of the tumor, evidence of local or distal spread, and patient characteristics and goals are all attributes that will affect treatment approach. Open, wide resections have the highest cure rate but may also have significant adverse effects. Most patients find the potential adverse effects of lifelong colostomy and/or bowel, bladder, or sexual dysfunction acceptable in the face of a terminal illness. Laparoscopic-assisted surgery, with lymph node dissection as indicated, is technically difficult in the pelvic region but is being investigated as a less invasive alternative to open resection.