Conference Coverage

Hopkins protocol aims to limit sarcoma morcellation risk

Key clinical point: In addition to the FDA’s recent morcellation contraindications, the procedure shouldn’t be done in women who have uterine sarcoma risk factors.

Major finding: There were two occult malignancies in a series of 424 morcellation cases at Johns Hopkins University, both in women over 50 years old.

Data source: A review of morcellation cases over 9 years.

Disclosures: The lead investigator reported having no financial disclosures.


 

AT THE AAGL GLOBAL CONFERENCE

References

VANCOUVER– To minimize the risk of spreading occult malignancy, Johns Hopkins University in Baltimore no longer uses uterine morcellation for fibroids or hysterectomies in women over age 50 years.

Morcellation is also contraindicated under the Hopkins protocol if women have other risk factors for gynecologic cancer, including tamoxifen use, pelvic radiation, hereditary cancer syndromes, and BRCA mutations.

For women who qualify, morcellation can be performed only by high-volume surgeons who isolate their targets within an endoscopy bag to catch spills. Case peer-review, endometrial sampling, and imaging – including an MRI for fibroids – are required beforehand to rule out occult malignancy, and women must be warned of the risk of occult malignancy before opting for morcellation.

Dr. Stephanie Ricci

Dr. Stephanie Ricci

“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.

She explained the protocol just days before the Food and Drug Administration released similar guidance, contraindicating power morcellation in peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case in the majority of hysterectomies and myomectomies. Women must also be warned of the risk of occult malignancy before morcellation, the agency said Nov. 24.

Taken together, the Hopkins’ protocol and the FDA’s guidance could help define the narrow pool of women for whom morcellation might still be an option, be it to preserve fertility or for some other reason.

“It’s possible that a higher rate of peer-review and preop imaging and endometrial sampling counter the risk of occult malignancy,” Dr. Ricci said at a meeting sponsored by AAGL.

Hopkins developed its rules in part based on a review led by Dr. Ricci of 424 morcellation cases there from 2005 to 2014. Two occult cancers were identified in women who underwent power morcellation, giving an incidence of 0.47%.

One case was a 55-year-old woman who presented with pain and hematometra. Her preoperative endometrial biopsy was negative, and she had a preop CT. She was morcellized with endoscopy bag containment and found to have invasive cervical adenocarcinoma. The second case was a 56-year-old women morcellized in 2009 for fibroids with no preoperative imaging, biopsy, or containment bag. She was found to have a uterine sarcoma. Both patients underwent chemotherapy and are currently without evidence of disease.

Almost 90% of the morcellation cases in the series were under age 50 years, 93% had preop uterine imaging, and almost half had preoperative biopsy.

“The one thing our institution has always done, and it speaks to the low rate of sarcoma we found in our study, is that all patients are [reviewed] in a preop gynecological oncology conference, even if they are being taken to the OR for benign indications,” Dr. Ricci said.

Dr. Ricci reported having no financial disclosures.

aotto@frontlinemedcom.com

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