The US Food and Drug Administration has recommended that the use of uterine smashers in laparoscopic uterine myomectomy and hysterectomy may cause unknown tumors to spread in the abdominal cavity, leading to an increased risk of disease. This proposal has caused tremendous repercussions and discussions. At one time, there were different opinions and no one.
And our experts suggest that, just like the usual sterility awareness during surgery, everyone should also establish a sense of no tumor, this consciousness should be implemented in the whole process of preoperative diagnosis, intraoperative operation and postoperative care.
The US Food and Drug Administration (FDA) recently recommended that the use of uterine pulverizers in laparoscopic myomectomy and hysterectomy may cause unknown tumors to spread in the abdominal cavity, leading to an increased risk of disease. instrument. The FDA has asked manufacturers to inspect the label of the relevant equipment (tissue pulverizer) and is considering adding a "black box" warning - this is the strongest warning the FDA can issue.
This proposal has caused tremendous repercussions and discussions. At one time, there were different opinions and no one. So, what is the pulverizer used in laparoscopic surgery, and how much risk it has, should we stop laparoscopic surgery to avoid risk?
the reason
Smashing can cause tumor spread
"Minimally invasive surgery is the general trend of surgical development and the pursuit of goals." Xiu Dianrong, director of the Third Hospital of Peking University, said in an interview with the reporter of the Chinese Journal of Science.
Laparoscopic surgery is a newly developed minimally invasive treatment method. Compared with traditional surgery, it is very popular among patients, especially after surgery, which has small scars and meets aesthetic requirements. Young patients are more willing to accept.
In layman's terms, laparoscopic surgery is a surgeon inserting a laparoscopic lens into the abdominal cavity of a patient, transmitting the intra-abdominal condition to the TV screen in real time, and performing an intra-abdominal operation through the abdominal puncture hole using an elongated instrument.
"The comminution tools used in minimally invasive surgery may indeed spread the sarcoma that was not detected before surgery," said Li Xiaoguang, director of the Department of Gynecology, Cancer Hospital, Chinese Academy of Medical Sciences.
"When uterine myomectomy is performed under laparoscopy, the fibroids to be removed are usually cut into small pieces with a pulverizer, and then the tissues are taken out through the operation holes." Li Xiaoguang said, "This operation mode, if Misuse of patients with uterine sarcoma may accelerate the progression of the patient's lesions."
Li Xiaoguang told reporters that the pulverizer produced small tumor tissue fragments during the rotary cutting process, and the tumor cells shed in the abdominal pelvic cavity, which would cause the iatrogenic tumor to be transplanted in the abdominal cavity. When the pulverizer is rotated, it may cause sarcoma tissue and cells to be crushed, broken, and locally infiltrated and grow, resulting in local recurrence of the tumor.
In fact, doctors have already sounded the alarm for the smashing technique. In 2011, Jeong-Yeol Park, a gynecologic oncologist at the Lushan Hospital in Seoul, Korea, compared the treatment of 56 patients with suspected leiomyosarcoma for hysterectomy.
The results showed a 5-year survival rate of 73% in 31 patients who did not receive comminution, compared with 46% of the 25 patients who underwent comminution.
"In the medical activities, the principle of oncology is the first. Compared with oncology, it is a icing on the cake. It cannot be inverted." Xiu Dianrong expressed his understanding of the FDA's proposal.
debate
It is not advisable to negate the minimally invasive
"However, I just don't agree with the idea that smashers and laparoscopic surgery are no longer used because of the risk of surgery." China-Asia-Pacific Association of Minimally Invasive Gynecologic Oncology (CP-AMIGO) expert committee, Southern Medical University, Zhujiang Liu Muzhen, deputy director of the Obstetrics and Gynecology Department of the hospital, said in an interview with the reporter of the Chinese Journal of Science.
Liu Muzhen introduced that the clinical uterine pulverizer is an important helper for gynecological minimally invasive surgery, so that a large number of patients with uterine fibroids removal and huge hysterectomy can enjoy the benefits of laparoscopic minimally invasive surgery.
"Most of the uterine malignancies can be diagnosed preoperatively, and the incidence of uterine sarcoma accounts for less than 3% in patients with fibroids. The proportion of patients who are completely misdiagnosed as benign before surgery will be lower." Liu Muzhen said, "Current laparoscopy Technology is very mature and standardized in the diagnosis and treatment of most diseases, and it can basically replace or even surpass the traditional surgical methods."
"The phenomenon that laparoscopic tumor dissemination is easier is not recognized by most people. Similarly, traditional surgical incision implantation, sinus metastasis exists." Xiu Dianrong also said that the surgical approach is not the cause of tumor spread, fatal The reason is tumor, not comminution.
"In any case, the surgical approach of uterine fibroids should be based on the patient's age, fertility requirements, the number of fibroids and growth sites, whether or not combined with other diseases, and the patient's subjective willingness to weigh the pros and cons." Liu Muzhen believes that "blind stop pulverizer is Some are overkill, and some are overkill."
solve
Establishing cancer-free awareness is the key
So, what can be done to reduce the risk of laparoscopic tumor spread?
Li Xiaoguang mentioned in the interview that it is very important that the doctor needs to have a sense of cancer. "Like the usual sterility awareness during surgery, everyone should also establish a sense of no tumor, this consciousness should be carried out in the whole process of preoperative diagnosis, intraoperative operation and postoperative care." Li Xiaoguang suggested.
"Before the operation, the patient's condition must be carefully evaluated. This is the most important measure to avoid the tumor-distributing tumor." Liu Muzhen believes that the patient's condition should be preliminarily collected through detailed medical history collection and necessary imaging examination. judgment.
For laparoscopic subtotal hysterectomy, uterine and cervical malignant lesions should be strictly excluded before surgery, which is suitable for any benign disease patients who are scheduled for laparoscopic surgery. "You can give a segmental curettage and check the tumor markers before surgery." Li Xiaoguang suggested that once the malignancy is suspected, avoid using a pulverizer, and remove the tumor or uterus completely through the abdomen or transvaginal.
"When the surgery is found to be beyond the pre-judgment, the operation under the microscope is more difficult, beyond the technical ability of the doctor, the surgeon can switch to the laparotomy according to the condition or choose other safer surgical methods." Li Xiaoguang said, "If the organization takes out It was found to be a malignant lesion. It is necessary to remove as much as possible the residual tumor fragments during the comminution. Repeated, large-scale abdominal irrigation is an effective method."
When talking about reducing the risk of laparoscopic dissemination, Xiu Dianrong said: "Strictly follow the oncology principle to treat the entire surgical procedure of the tumor patient, including the specimen to be delivered in the specimen bag, not to squeeze the tumor during surgery, etc. There are many specific The operational considerations reduce these things. However, the most fundamental factor is actually the biological behavior of the tumor itself, which plays a very important role in the prognosis of cancer patients."
Reflection
New technology requires data support and regulatory supervision
It is worth rethinking that medicine is still unknown in medicine. Sometimes, the pursuit of novelty and skill in surgery has caused new pain. Xiu Dianrong mentioned that China lacks large case data, and the introduction and use of many new technologies lacks supervision and even blindly expands the indications. This problem needs to cause us to think.
Although the current large number of laparoscopic surgery in China has benefited many patients, it is undeniable that many hospitals, especially some hospitals at the grassroots level, have imperfect techniques in the use of laparoscopy, and the surgical indications are not tightly controlled. This is a big hidden danger.
"In fact, the most important indication for laparoscopic surgery is the doctor's skill. Starting from taking the mirror, step by step training and accumulation, can you truly grasp the mystery." Xiu Rongrong said, "Otherwise, even if there are clear indications, technology If it is not in place, it will cause the patient to be hurt."
Liu Muzhen believes that when the pulverizer and laparoscope should be used, when should not be used, how to reduce the risk of disseminating tumors, etc., it is necessary to analyze and study a large number of clinical cases to draw conclusions.
[As a general use of uterine pulverizers in China, our corresponding academic groups should take active actions and organize experts to evaluate them instead of waiting for foreign data." Liu Muzhen suggested, [After all, the incidence of uterine sarcoma varies from country to country. The risk of tumor spread is naturally different."
"All in all, the warnings put forward by the FDA, we need to pay attention to it, but we cannot completely negate the past experience because of the waste of food, thus damaging the interests of most patients." Liu Muzhen believes.
Related Reading
Laparoscopy
Laparoscopy is a device with a miniature camera. Laparoscopic surgery is performed using a laparoscope and related instruments. After surgery, only 1 to 3 linear scars of 0.5 to 1 cm were left in the abdominal cavity. It can be said that the operation is small and the pain is small. Therefore, some people call it "keyhole" surgery.
In 1901, Ott, a gynaecologist in Petersburg, Russia, made a small incision in the anterior wall of the abdomen, inserted a vaginal device into the abdominal cavity, and reflected the light into the abdominal cavity with a cephaloscope to examine the abdominal cavity.
In the same year, German surgeon Kelling inserted a cystoscope into the abdominal cavity of the dog for examination and said that the examination was a laparoscopic endoscopy.
In 1910, Jacobeaus of Stockholm, Sweden, first used the term laparoscopy, which used a trocar to make a pneumoperitoneum.
In 1911, Bernhein, a surgeon at Johns Hopkins Hospital in the United States, inserted a rectaloscope into the abdominal cavity through an incision in the abdominal wall and used the emitted light as a light source.
In 1924, Kansas, a physician in Kansas, USA, inserted a nasopharyngeal mirror into the abdominal cavity of a dog and recommended a rubber gasket to help close the puncture cannula to avoid air leaks during operation.
In 1938, the Hungarian surgeon Veress introduced a gas injection needle that can be safely made into a pneumothorax. When doing pneumoperitoneum, it can prevent the needle tip from damaging the internal organs under the needle. The idea of making a pneumoperitoneum with a compromised safety puncture needle is generally accepted and is still in use today.
The inventor of the true targeted abdominal examination was German gastroenterologist Kalk, who invented a 135° lens system with a straight forward strabismus. He is believed to be the founder of laparoscopic surgery for the diagnosis of liver and gallbladder disease in Germany. In 1929 he first advocated the use of double-sleeve puncture needle technology.
In 1972, the American Gynecologic Laparoscopic Physician Association planned to complete nearly 500,000 cases of abdominal examination in the next few years. This type of examination has been widely accepted by gynecologists. Nearly one-third of gynecologic operations at the Cedars-Sniai Medical Center in Los Angeles use diagnostic or therapeutic laparoscopy.
In 1986, Cuschieri began an animal experiment of laparoscopic cholecystectomy. At the first World Congress of Surgery Endoscopy in 1988, he reported that a laboratory animal was successfully treated with laparoscopy for cholecystectomy and was applied to the clinic in February 1989.
Philipe Mouret, a French surgeon who succeeded in laparoscopic cholecystectomy for the first time in humans, succeeded in performing laparoscopic cholecystectomy in the same patient with laparoscopic 1987, but did not report it.
In May 1988, Dubois of Paris applied it to the clinic on the basis of laparoscopic cholecystectomy experiments in pigs. The results were first published in France and presented at the annual meeting of the American Society of Digestive Endeurists in April 1989. The video of the operation made a sensation in the world. It first shocked the American surgical community, and the craze of laparoscopic cholecystectomy in the United States led to laparoscopic cholecystectomy from the animal experiment, clinical exploration stage to the clinical development stage.
In February 1991, Zhai Zuwu completed the first laparoscopic cholecystectomy in China, the first laparoscopic surgery in China.
Laparoscopy has become a new branch of modern surgery. As a revolution, modern laparoscopic surgery is developing rapidly. At present, laparoscopic surgery mainly involves three disciplines: general surgery, gynecology, and urology. It also involves partial surgery in pediatrics, vascular surgery, orthopedics, and abdominal surgery. (Chengjie finishing)
Source: Chinese Journal of Science