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May07
Staging Laparoscopy for Pancreatic Adenocarcinoma
Rationale for the Procedure
Pancreatic adenocarcinoma is diagnosed in just over 30,000 patients every year in the United States and has a dismal prognosis, with an almost identical yearly death rate. Surgery is the only modality that can lead to cure; however, most patients present with inoperable disease. The overall 5-year survival is <5%. Patients with localized disease have a 15% 5-year survival after curative resection. In a disease with such a poor prognosis even after curative resection, it is not only important to identify patients with resectable disease but also to spare patients with incurable disease the morbidity, inconvenience, and expense of an unnecessary operation. Thus, accurate staging of pancreatic adenocarcinoma is of paramount importance. A high quality CT scan of the pancreas is considered the best initial diagnostic modality for this disease. Nevertheless, even after appropriate preoperative imaging, 11-48% of patients are found to have unresectable disease during laparotomy. For this reason, many authors have introduced SL in the treatment algorithm of pancreatic adenocarcinoma patients in an effort to decrease the number of unnecessary laparotomies.
Technique
The feasibility of SL has been demonstrated in multiple studies with success rates ranging from 94-100% (level II, III). Dense adhesions that impair inspection and examination with the ultrasound probe are the main reason for technical failures. Nevertheless, even patients with adhesions can be examined; however, the extent and yield of the examination may be compromised. Conversions to open surgery are uncommon and have been reported to occur in <2% of patients in a large series (level III) [5].
The procedure is usually performed under general anesthesia, and the majority of reports have used 15 mm Hg insufflation pressures. A thorough evaluation of peritoneal surfaces is performed. The suprahepatic and infrahepatic spaces, the surface of the bowel, the lesser sac, the root of the transverse mesocolon and small bowel, the ligament of Treitz, the paracolic gutters, and pelvis are inspected with frequent bed position changes as necessary. In addition to visual inspection, peritoneal washings can be performed, ascitic fluid, if present, sent for cytology, and biopsy specimens of lesions suspected to be malignant obtained. When no metastatic disease is identified on inspection, a detailed laparoscopic ultrasound examination can be employed during which the deep hepatic parenchyma, the portal vein, mesenteric vessels, celiac trunk, hepatic artery, the entire pancreas, and even pathologic periportal and paraaortic nodes can be evaluated and biopsied. The addition of color flow Doppler can further assist in the assessment of vascular patency.
A controversy exists in the literature about the extent of SL for pancreatic adenocarcinoma patients. Advocates of a short duration procedure that is based only on inspection of abdominal organ surfaces argue that the procedure can be performed quickly (usually within 10–20 min), can be done through one port, does not require significant expertise, minimizes the risk of potential complications by the dissection near vascular structures, and has good diagnostic accuracy (level III) [1,2]. On the other hand, advocates of a more extensive procedure that includes opening the lesser sac and assessment of the vessels argue that the diagnostic accuracy of the procedure can be enhanced by detecting metastatic lesions in the lesser sac, vascular invasion by the tumor, or deep hepatic metastasis, often missed by visual inspection alone, and that it can be performed safely without a significant increase in morbidity and within a reasonable time (level II, III) [3-5].
It is very important, therefore, to consider these differences in the SL technique when evaluating reports of the diagnostic yield of this procedure in patients with pancreatic adenocarcinoma.
Indications
• As a staging procedure for pancreatic adenocarcinoma
• For detection of imaging occult metastatic disease or unsuspected locally advanced disease in patients with resectable disease based on preoperative imaging prior to laparotomy
• For assessment prior to administration of neo-adjuvant chemoradiation
• For selection of palliative treatments in patients with locally advanced disease without evidence of metastatic disease on preoperative imaging
Contraindications (Absolute or Relative)
• Known metastatic disease
• Inability to tolerate pneumoperitoneum or general anesthesia
• Multiple adhesions/prior operations
Risks
• False negative studies that lead to unnecessary exploratory laparotomies and unnecessary cost
• Procedure-related complications
Benefits
• Avoidance of unnecessary exploratory laparotomy with its associated higher morbidity and cost in patients with metastatic disease
• Appropriate selection of patients with true locally advanced disease and exclusion of patients with CT-occult metastatic disease from further unnecessary treatment (chemotherapy or chemoradiation) with its associated morbidity and cost
• Minimizes the delay of primary treatment (chemotherapy or chemoradiation) in the subset of patients whose disease is unresectable by avoiding laparotomy and its associated longer convalescence period
Diagnostic Accuracy of the Procedure
The reported median (range) sensitivity, specificity, and accuracy of SL in detecting imaging-occult, unresectable pancreatic adenocarcinoma in the literature is 94% (range, 93-100%), 88% (range, 80-100%), and 89% (range, 87-98%), respectively (level II, III) [2-23]. However, the procedure misses 6% (range, 5-25) of patients whose disease is identified as unresectable during an ensuing laparotomy (level II-III) [2-23]. Overall, in 4-36% of patients, an unnecessary laparotomy can be avoided (level II-III) [2-23].
A number of studies have also evaluated the added benefit of laparoscopic ultrasound at the time of laparoscopic staging indicating that the diagnostic accuracy of the procedure can be improved by 12-14% (level II-III) [3-8,19-22]. In addition, peritoneal washings have been reported to augment the yield of the procedure. Reports on the sensitivity of peritoneal washings have ranged widely (25-100%) [2,17,24-26]. The highest sensitivity for peritoneal cytology has been reported in patients with a disrupted ventral pancreatic margin (when peripancreatic fatty tissue cannot be differentiated from the tumor by helical CT scan) (level III) [26]. In addition, locally advanced pancreatic cancers have a higher incidence of positive cytology (level III) [12,17,27]. Importantly, studies have reported a 7-14% incidence of positive peritoneal washings in the absence of other findings of metastatic disease during preoperative imaging and SL (level III) [2,17]. This incidence seems to be lower in studies that include a variety of periampullary tumors (level II) [14].
The diagnostic yield of the procedure also depends on the histology, stage of disease, tumor size, and location. There is convincing evidence that the yield of SL is significantly higher in patients with pancreatic cancer compared with other types of periampullary tumors (level III) [11,12,16,23]. Furthermore, SL appears to have a higher yield in patients with locally advanced cancer compared with patients with localized disease. Identification of metastatic disease by SL in patients with locally advanced disease by high quality imaging studies has been reported in 34-37% of cases, which compares favorably with the identification rates of metastatic disease in patients with localized disease (level III) [1,27,28].
Tumors of the pancreas body and tail are associated with a higher chance for unsuspected metastasis found at laparoscopy (level III) [2,17]. Larger tumors appear to be associated with a higher incidence of imaging occult metastatic disease (level III) [12,23,29,30]. Although the tumor size at which the risk of occult M1 disease justifies the added time and cost of laparoscopy is currently unknown, some studies have suggested that tumors > 3 cm are more likely to be associated with metastatic disease at exploration (level III) [29,30]. Moreover, a Ca 19-9 level <150 has been associated with a lower chance for metastatic disease and consequently a lower yield for SL (level III) [31].
Procedure-related Complications and Patient Outcomes
Procedure-related morbidity has been reported to range 0 and 4% (level II, III) [1-30]. Most complications are minor and consist of wound infections, bleeding at port sites, or skin emphysema. Nevertheless, complications such as myocardial infarction, pulmonary embolism, and intestinal or vascular injury during the procedure have been described. The majority of the literature reports mortality rates of 0% (level II, III) [1-30]; however, at least one death has been reported due to a missed colonic injury during the procedure. Although studies comparing open and laparoscopic staging are scarce, the morbidity and mortality rates reported in the literature compare favorably to reports of negative exploratory laparotomies. No studies compare a short-duration inspection-only SL with a more extended procedure.
With regard to oncologic safety, initial concerns for more port-site recurrences after laparoscopic procedures in cancer patients have not been substantiated. Multiple studies report a 0-2% incidence of port-site recurrences after SL, which is similar to the incidence after open explorations of cancer patients (level III) [8,23,32]. In one comparative study of 235 patients who had undergone exploratory laparotomy or SL, laparoscopy was not associated with increased port-site recurrences or peritoneal disease progression (level III) [32]. Furthermore, there is evidence from the Surveillance Epidemiology and End Results (SEER) database suggesting no survival differences between pancreatic cancer patients who underwent a laparoscopic procedure compared with an open surgery (level II) [33].
Hospital length of stay after SL has been reported to range from 1 to 4 days [23]. Level III evidence suggests that the hospital stay is shorter after laparoscopic staging compared with open staging in pancreatic cancer patients [10].
In patients with locally advanced disease, SL has been reported to be superior to exploratory laparotomy, as it decreases length of hospital stay, increases the number of patients who receive chemotherapy, and shortens the time to initiation of such treatment (level III) [18,32].
Cost-effectiveness
Although high quality evidence on the cost effectiveness of SL is lacking, the literature suggests that SL is more cost-effective than open exploration when it is the only procedure required (i.e., in patients with unsuspected metastatic disease identified during SL) (level II) [34]. This is a consequence of decreased patient length of stays. On the other hand, the cost-effectiveness of SL when applied in the diagnostic algorithm of all pancreatic cancer patients appears to be linked directly to the yield of the procedure in identifying patients with imaging occult disease. In a cost utility analysis of the most effective management strategy for pancreatic cancer patients, at least a 30% yield was needed for SL to be more cost-effective than open exploration (level III) [35].
Literature Controversies
The main controversy regarding SL is whether it should be used routinely or selectively in patients with pancreatic adenocarcinoma deemed resectable on preoperative imaging. Proponents for the routine use of SL cite the high incidence of imaging occult metastatic disease found during laparoscopic examination of the abdominal cavity that leads to avoidance of unnecessary operations and thus benefits patients [3,20,27]. Proponents for the selective use of SL argue that when high quality imaging is used, only a small percentage of patients benefit from SL, and under these circumstances the procedure is not cost-effective [12,14]. As discussed in the technique section, there is also a controversy about whether to perform a limited or extended procedure.
Limitations of the Available Literature
The quality of the available studies on SL for patients with pancreas cancer is limited; no level I evidence exists. Furthermore, population-based data are very limited, as the majority of studies are single institution reports from highly specialized centers, making generalizations difficult and allowing institutional and personal biases to be introduced into the results.
In addition, reported data are not uniform across studies, making their analysis difficult. A number of studies assess the role of laparoscopy indirectly without having ever performed a single laparoscopic staging procedure (referred to as ‘phantom’ studies by some authors) and assume that only visible metastatic disease would have been detected at the time of laparoscopy, ignoring the value of laparoscopic ultrasound and cytology. Other studies do not clearly report the quality of preoperative imaging, the criteria used to define resectability, and the number of R0 resections. Importantly, studies often evaluate inhomogeneous patient samples, including patients with localized and locally advanced pancreatic cancers, with periampullary and other non-pancreatic cancers or even with benign disease and do not report results separately. Moreover, the information on the cost-effectiveness of the procedure is limited, and there are no studies that assess the quality of life of patients undergoing SL compared with patients undergoing open exploration.
Recommendations
Staging laparoscopy can be performed safely in patients with pancreatic adenocarcinoma (grade B). The procedure should be considered after high quality imaging studies have excluded metastatic disease in appropriately selected patients with either localized or locally advanced pancreatic adenocarcinoma (grade C). The use of laparoscopic ultrasound and peritoneal washings is encouraged, since they may improve the diagnostic accuracy of the procedure (grade C). Based on the available evidence, selective rather than routine use of the procedure may be better justified and more cost-effective (grade C). Patient selection may be based on the available evidence that suggests that the diagnostic accuracy of SL may be higher in patients with larger tumors, tumors of the neck, body, and tail or with clinical, laboratory (such as higher levels of Ca 19-9), or imaging findings suggestive of more advanced disease (grade C). Nevertheless, the effectiveness of such selection criteria needs to be verified by additional prospective studies.
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