Release date: 2015-01-12
With the advancement of surgical techniques, the surgical resection rate and perioperative safety of pancreatic cancer have been greatly improved in recent years, but the treatment effect has not improved significantly. The overall 5-year survival rate of patients is still less than 5%. Even after surgical resection, The patient died of tumor recurrence or metastasis more than 1-2 years after surgery. Pancreatic cancer has the worst prognosis in digestive tract tumors and treatment is challenging.
At present, there are many medical institutions that can carry out pancreatic cancer treatment in China, but the medical level varies greatly. In particular, consensus or guidelines are needed to guide clinical practice to standardize and constrain the diagnosis and treatment behavior and improve the level of diagnosis and treatment. In addition, the concept of treatment has undergone major changes in recent years, gradually shifting from “Surgery First†to “multi-disciplinary team (MDT)â€. In the above context, it is even more necessary to update and revise the previous guidance literature to reflect cognitive progress and academic progress, as well as academic exchanges and international standards.
I. Guidelines and guiding principles for the revision of the guidelines
In 2007, the Pancreatic Surgery Group of the Chinese Medical Association Surgery Branch published the Guidelines for the Diagnosis and Treatment of Pancreatic Cancer. In 2010, the Expert Consensus on the Prevention and Treatment of Common Complications in Pancreatic Surgery (2010) was published. Very high, playing a very positive role in leading and regulating the clinical practice of pancreatic cancer in China. In recent years, other professional institutions and academic groups in China have published a number of consensus literatures from different professional perspectives, such as "Guidelines for Transcatheter Chemotherapy of Pancreatic Cancer (Draft)", "Expert Consensus of Multidisciplinary Comprehensive Treatment Collaboration Group for Pancreatic Cancer", Comprehensive Diagnosis and Treatment of Pancreatic Cancer Chinese Expert Consensus, etc.
Foreigners are more active, and the more influential NCCN Guidelines for Pancreatic Cancer is updated every year. The International Study Group for Pancreatic Surgery (ISGPS) recently published three consensus papers in Surgery for current hotspots in pancreatic surgery, such as lymph node dissection, definition of different pancreatectomy, and possible removal of the pancreas Cancer and other aspects have been discussed in depth. The organization is composed of dozens of well-known pancreatic surgeons in Europe, America and Asia, and has a wide range of academic representatives and influence.
The above-mentioned domestic and international consensus or guidelines provide an important reference for the revision of this guideline, guided by evidence-based medicine, based on the published literature in recent years, especially the randomized controlled trial (RCT), and combined with domestic clinical The actual situation is the basic principle of the revision of this guide. This guideline development work strives to standardize the definition standards, highlight the characteristics of the disciplines and focus on international standards, making the guidelines more scientific, guiding and authoritative.
Second, the method and process of the revision of the guide
After the start of the revision work, the Pancreatic Surgery Group appointed two experts to complete the first draft, and then all the members of the school group concentrated on the first draft for in-depth and meticulous discussion and proposed amendments. Then, according to the discussion opinions, the revised draft was completed and sent to each member of the school group by email. According to the comments of the review, it was revised and improved again, and it was sent to each member of the school group for review, and the final review was submitted. After the revision, the final draft was formed. The whole process lasted nearly 4 months. The revision of this guide reflects the collective efforts and consensus of all members of the Pancreatic Surgery Group.
Third, the basic concepts clearly put forward
(1) Evidence-based level problem
Current guidelines or consensus literature are mostly based on evidence-based medicine, with a clear evidence-based level of representation, but with different forms of expression. According to the level of evidence, there are documents expressed as 1, 2A, 2B, 3; also expressed as A, B, C, D; and the literature is expressed as recommended (strong) and weak (weak) according to the recommended level. Then, it is divided into three categories: conditional, discretionary, and qualified. Although the form of expression is different, the content is basically the same and is divided into 4 different levels. This guide uses the first form of expression. Because the clinical research of pancreatic cancer is rarely based on the large sample size of the RCT study, the empirical conclusions are still the main reference, so this guide is the Category 2A recommendation except for the special logo.
(two) pancreatic CT and pancreatic MRI
In recent years, imaging has developed rapidly and is extremely important for the assessment of resectability of pancreatic cancer. In imaging examination, special technical parameters should be set for pancreatic lesions, including thin layer (<3 mm), plain scan, arterial phase, parenchymal phase, portal vein phase and three-dimensional reconstruction to accurately describe tumor size, location, presence or absence. Lymph node metastasis, especially the structural relationship with peripheral blood vessels.
(3) Defining the scope of lymph node dissection
This guideline clearly defines the pancreaticoduodenectomy and pancreatic body and tail resection criteria and the expanded lymph node dissection. It is graphically represented to facilitate clinical practice reference and academic exchanges.
(4) Defining the scope of resection of different surgical procedures
The extent of resection mainly refers to surrounding organs or blood vessels. This guideline is aimed at pancreaticoduodenectomy, pancreatic body and tail resection and total pancreatectomy. The surrounding organs or blood vessels that should be included in the standard and enlargement procedures are clearly defined. It is not recommended to apply the joint dirty. The term "removal" refers to the removal of other organs other than the pancreas due to standard procedures.
(5) Standards for RO resection (negative margin of margin)
The criterion for cutting margin is a hot issue in recent years. In the past, due to different standards, there was no difference in the recurrence rate and prognosis between RO and R1 (microscopically positive margin) resection in the literature, and the comparability between the studies was poor. In recent years, the international literature has reached a consensus that the principle of “1 mm†is used as the criterion for judging that the tumor-free cells with a margin greater than 1 mm are removed by RO, otherwise R1 is removed. This guide clearly states that the resection of most pancreatic cancers is R1 resection, which is determined by the specific anatomy of the pancreas and the adjacent relationship between the tumor and the surrounding large blood vessels.
(6) Palliative resection
In previous literature, the expression of palliative pancreaticoduodenectomy was more ambiguous, and those with positive margins (R1 and R2) were palliative resection. According to the current new evaluation criteria for marginectomy, palliative resection refers to R2 resection (recognized by the naked eye).
Fourth, several hot issues
(1) About preoperative pathological diagnosis
For patients with clear imaging diagnosis and indications for surgery, this guideline has a clear view: no pathological diagnosis is required before the resection, and surgery should not be delayed waiting for pathological diagnosis. The main basis is as follows.
1. The safety of pancreaticoduodenectomy during perioperative period is much better than before. Although the incidence of postoperative complications is higher, the operative mortality rate is less than 3%. The safety of the operation itself is to actively treat the head of the pancreas. The lesions provide the basis.
2. Imaging technology is developing rapidly, and it can make accurate judgments on the nature and resectability of pancreas.
3. Some benign lesions of the head of the pancreas, such as mass-type chronic pancreatitis, sulcus pancreatitis, etc., based on its potential malignancy and improving the clinical symptoms of patients, even if it is a benign place, there are indications for surgical resection.
4. The cell or histological examination of various paths before surgery has limitations, and there may be false negatives, that is, positive results support diagnosis, specificity is strong, but negative results are difficult to rule out diagnosis, and sensitivity is poor.
This guide places special emphasis on the need to communicate fully with patients and their families. Clinical medicine is a practice science, and any examination has limitations, and any decision has potential risks. In the above-mentioned “uncertaintyâ€, sufficient reporting obligations should be fulfilled to obtain the understanding and support of patients and their families, and the doctors and patients share the potential risks after decision-making.
(B) several cases of pathological diagnosis before treatment
This guide clearly states that the following conditions must be pathologically diagnosed before further treatment can be implemented.
1. Patients with neoadjuvant therapy for potentially resected pancreatic cancer must have a clear pathological diagnosis.
2. Unresectable pancreatic cancer patients undergoing radiotherapy must be supported by pathological diagnosis.
3. Open laparotomy revealed that the tumor was unresectable, and patients who were scheduled to undergo palliative short-circuit therapy should obtain pathological diagnosis results during the operation to guide the follow-up adjuvant therapy.
(3) About the scope of lymph node dissection
The extent of lymph node dissection in pancreatic cancer resection has been controversial for more than 10 years. The recommended scope for the release of the guidelines, the surgeons are not highly compliant in specific practice, and there are many surgeons who advocate and practice the expansion of the scope of cleaning. In the 1990s, Japanese scholars advocated a wide range of lymph node dissection, but most of them were single-center retrospective studies, and the evidence-based level was not high.
After 2000, European, American and Japanese scholars reported four prospective studies. The results showed that the expanded lymph node dissection did not show an advantage in improving the prognosis of patients compared with the standard lymph node dissection. However, the RCT study mentioned above generally has a small sample size, and there is a lack of bias in comparability between studies. Although there have been very few literatures on this topic in Europe and the United States in recent years, it has been objectively indicated from the academic level that the scope of lymph node dissection is not a hot topic, but Asian countries have shown more concern on this topic.
Two recent RCT studies in Japan and South Korea have examined the clinical significance of expanding the extent of lymph node dissection. Compared with the standard surgery group, the expanded group did not show an improvement in prognosis. These two studies are superior to previous RCT studies in terms of research quality, but there is still a problem of small sample size. Based on the above research results, although there has been some consensus on this issue at home and abroad, there is still much controversy. In the coming period, this issue will continue to be a research hotspot. This guide promotes clinical research on this subject, but in routine clinical work, a standard range of lymph node dissection is recommended.
(D) on the treatment of possible removal of pancreatic cancer
The core problems in the treatment of possible resected pancreatic cancer include two aspects, one is combined with vascular resection, which is safety evaluation; the other is whether RO resection can be achieved, that is, effectiveness evaluation. At present, there is a more positive treatment concept for the combined superior mesentenc veln (SMV) and portal vein (PV) resection. Based on safety, some scholars believe that locally affected SMV or PV can be directly surgically removed without the need for neoadjuvant therapy.
The reason for the difference in survival between patients with combined SMV and PV resection, and thus the validity of this, is partly due to the fact that some patients with poor prognosis are actually R1 or even R2 resection. Some scholars reviewed the data of 52 patients with pancreaticoduodenectomy combined with SMV and PV resection, and concluded that patients with SMV and PV resection were more likely to have positive margins (40.5%) and lymph node metastasis (67. 4%). .
Based on this, it is more advocated to perform neoadjuvant radiotherapy and chemotherapy on patients with possible resected pancreatic cancer to improve the RO resection rate. Regarding the effectiveness of neoadjuvant therapy, the lack of a large sample of RCT studies confirms that treatment options and cycles are also inconsistent. This guide promotes a multicenter, prospective study of this topic.
(V) Promote standardized testing of pancreaticoduodenectomy specimens
This guide lists the standardized testing of specimen cutting margin as one of the important contents, and the specifications for visual inspection and microscopic examination are described in detail. In the past, no matter whether the surgeon or the pathologist is concerned about this, especially some surgeons or postgraduates often take the materials after the specimens are removed. The specimens have been destroyed before being sent to the pathology department, which affects the accuracy of the follow-up pathologist. judgment. This guide advocates that the surgeon and the pathologist work together to dispose of the complete specimen, marking the pancreatic neck, SMV and PV grooves, the right side of the SMA and the posterior margin of the uncinate process with different color dyes, and the multiple materials are examined under the microscope, especially It should be noted that the retroperitoneal margin of the specimen that is most prone to a positive margin is the right side of the SMA.
(6) The significance of R1 resection under the new standard
As mentioned above, with the "1mm principle" as the criterion, most pancreatic head cancers are R1 resected. In previous literatures, palliative resection compared with short-circuit surgery did not help to improve the prognosis of patients, and palliative pancreaticoduodenectomy was not recommended. How to re-evaluate the R1 and R2 margins under the new standard and MDT mode is a problem that currently plagues surgeons. Limited prospective studies have shown that R1 resection can significantly improve patient outcomes compared with double-short surgery.
R0 resection should be advocated for the purpose of surgery. However, due to the particularity of the anatomical location of the head of the pancreatic head, R1 resection is often used as the surgical result, but the prognosis can still be improved and can be implemented. R2 resection compared with double-short surgery does not help to improve the patient's prognosis, more than a short-term local recurrence or distant metastasis. Preoperative resectability assessment, MDT discussion, and intraoperative exploration should be used to avoid R2 resection.
Due to the differences in the practitioner's practical experience and the individualized differences of patients, the treatment of pancreatic cancer is extremely complicated, and it is difficult to have an absolutely consistent result in the evaluation of a specific diagnosis and treatment behavior, especially the lack of high-level evidence-based support. At present, the consensus or guideline literature on pancreatic cancer still stems from empirical evidence.
Therefore, it is necessary to look at and evaluate the guidelines from a development perspective. It also reflects the limitations of the guidelines and the need to continually update the amendments, but this does not prevent the guidance of the guidelines from guiding clinical practice. It is the clinical significance, through the accumulation of experience to continuously improve and guide the clinical, to avoid detours and repetitive errors, is the significance of the development of guidelines.
Source: Chinese Journal of Surgery
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