Thyroidectomy

Thyroidectomy Beneficial but Risky for Hashimoto Disease

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TOPLINE:

In patients with Hashimoto disease and persistent symptoms despite adequate medical treatment, total thyroidectomy had a beneficial effect up to 5 years but with a substantially higher risk for complications than initially anticipated.

METHODOLOGY:

  • The 5-year follow-up of 65 participants in a randomized, open-label trial of thyroidectomy plus medical management vs medical management alone aimed at testing the hypothesis that persistent symptoms despite adequate thyroxine replacement may be related to extrathyroidal autoimmune reactions and that complete removal of thyroid tissues may attenuate autoimmune responses and relieve symptoms.
  • Patients in the control group were given the option of having surgery 18 months after enrollment, depending on trial results.
  • The primary outcome was patient-reported health-related quality of life measured by the dimensional general health score in the generic Short Form-36 Health Survey questionnaire.

TAKEAWAY:

  • The positive treatment effect seen after 18 months was maintained throughout the 3-year follow-up.
  • In the intervention group, the improved general health score remained at the same level during the 5-year follow-up.
  • Results were similar for the other Short Form-36 Health Survey domains and for total fatigue and chronic fatigue.
  • Short-term (<12 months) or longer-lasting complications occurred in 23 patients, including 6 with recurrent laryngeal nerve paralysis (4 were long-term) and 12 with hypoparathyroidism (6 long-term, including 3 permanent).
  • Five patients had postoperative hematoma and/or infection requiring intervention.

IN PRACTICE:

“The improvements in patient-reported outcome measures reported at 18 months after surgery were maintained at 5 years after surgery in the intervention group. In contrast, no spontaneous improvement was seen during 3 years in the control group.”

“Long-term complications in 10 of 73 (14%) patients despite use of meticulous dissection to achieve total thyroidectomy is unacceptably high. Medication and compensatory mechanisms for hypoparathyroidism and unilateral recurrent nerve injury, respectively, did alleviate symptoms.”

Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer.

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BACKGROUND: In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits.

METHODS: In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization.

RESULTS: Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of -0.3 percentage points (two-sided 90% CI, -2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported.

CONCLUSIONS: In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years. 

Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer

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Abstract

BACKGROUND

In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits.

METHODS

In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization.

RESULTS

Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of −0.3 percentage points (two-sided 90% CI, −2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported.

CONCLUSIONS

In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years.

New approaches to thyroidectomy prompt discussion.

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During an academic debate held here, two presenters focused on the pros and cons of conventional vs. minimally invasive approaches to thyroidectomy.

In the process, some of the concerns that patients now harbor, particularly in terms of cosmetic effects, came to the forefront.

“The frontiers of thyroidectomy today focus on minimizing pain and maximizing cosmesis and preventing long hospital stays,” Carmen C. Solorzano, MD, professor of surgery and director of the Vanderbilt Endocrine Surgery Center, said during a presentation at the American Thyroid Association 82nd Annual Meeting.

‘Gold standard‘

Conventional thyroidectomy consists of a Kocher incision and requires elevation of large flaps, often with the use of a surgical drain, to allow complete exposure of the thyroid gland, according to Solorzano, whereas a minimally invasive approach involves an incision in the cervical area that is small and requires less extensive dissection. These approaches include minimally invasive video-assisted thyroidectomy (MIVAT), minimal incision and endoscopic minimally invasive thyroidectomy, but not remote approaches to the thyroid gland, such as the robotic facelift thyroidectomy.

Solorzano, who spoke in favor of the conventional approach, noted that a meta-analysis showed that the rate of recurrent nerve palsy between the two approaches was the same, although cosmetic satisfaction and pain scores were better in the minimally invasive thyroidectomy group. The conventional approach, however, was associated with shorter operative times, lower cost and wider applicability, she said. Additionally, conventional thyroidectomy remains the standard approach for Graves’ disease, which usually involves very large glands, and bulky cancer, as these would be difficult to remove through small incisions.

“The fact remains that one of the drawbacks to the minimally invasive approach is that it is only appropriate in about 5% to 30% of cases,” Solorzano said. “Major limitations are thyroid size, thyroiditis or toxic glands and cancer or adenopathy.”

Nevertheless, patients can still experience the benefits associated with minimally invasive surgery, according to Solorzano, as long as surgeons adapt by considering cosmesis with smaller incisions in the skin crease, using magnification and lighting, and paying attention to the edges of the wound.

“The conventional thyroidectomy remains the gold standard approach to removing the thyroid gland,” Solorzano said. “The minimally invasive approach remains an option but is limited by thyroid size and pathology.”

For select patients

Although not appropriate for all, according to Maisie L. Shindo, MD, FACS, patients and physicians may benefit from the MIVAT approach, which is similar to a laparoscopic procedure in which a high definition camera is used that allows the surgeon to dissect using a monitor.

“An advantage of the high definition camera is you can really see the nerve in magnified view and then just take out the thyroid,” Shindo, who is director of thyroid and parathyroid surgery at Oregon Health & Science University, said.

She also cited data from several studies suggesting that patients who underwent MIVAT experienced somewhat better outcomes vs. those who underwent conventional thyroidectomy. In a 2002 prospective study comparing post-operative pain at 24 and 48 hours after the procedure, for instance, indicated that post-operative pain was better in the MIVAT group. Similarly, a 2004 study showed that patients in the MIVAT group experienced better cosmetic and pain results than those in the conventional approach group.

Additionally, a study comparing minimally invasive thyroidectomy without video with mini-incision revealed that pain was significantly lower among patients who underwent surgery with the minimally invasive approach, according to Shindo.

She expressed concern, however, about the use of MIVAT in patients with thyroid cancer where the surgeon would likely be performing a total thyroidectomy and potentially removing lymph nodes as well, and noted that becoming skilled in using MIVAT requires time.

“My argument is that MIVAT is safe with the appropriate patient selection,” Shindo said. “It does provide a small incision and less pain, but there is a learning curve like with any other laparoscopic procedure. You have to be very experienced because there can be anatomic variations, so you have to be aware of that.”

Perspective

 

David J. Terris

  • I thought both of the speakers made very balanced and informed presentations. It’s always a challenge assessing new technology and new procedures, and I thought they both did a great job of presenting fair arguments about the procedures.

Much of the discussion was about minimally invasive techniques, but there was mention of robotic surgery, and it was clear that neither speaker was necessarily supportive of that approach. I think they drew an important distinction between minimally invasive surgery and robotic remote access surgery conventional techniques because sometimes the lines get blurred by the uninformed who may think that robotic surgery must be minimally invasive. For other procedures, such as robotic prostatectomy, it is. In many respects, it is minimally invasive, but when we refer to thyroid surgery and remote locations like the armpit or behind the ear, there’s more dissection involved just to get to where the thyroid gland is. The reason the robot is so valuable in those cases is because you’re working down a long tunnel and you can use these very minitaturized instruments to a) provide tremendous 3-D visualiation and b) the maneuverability of the instruments in that small space is so superior that if you’re going to do remote access surgery, it’s much easier if you use the robot. But the overall technique itself, the remote access techniques, is more invasive, but I was pleased to see that each of the speakers kind of emphasized that point.

Source: Endocrine Today.