Insights from managing clinical issues in distal pancreatectomy with en bloc coeliac axis resection: experiences from 626 patients.

BACKGROUND: Distal pancreatectomy with en bloc coeliac axis resection (DP-CAR) for pancreatic body cancer has been reported increasingly. However, its large-scale outcomes remain undocumented. This study aimed to evaluate DP-CAR volume and mortality, preoperative arterial embolization for ischaemic gastropathy, the oncological benefit for resectable tumours close to the bifurcation of the splenic artery and coeliac artery using propensity score matching, and prognostic factors in DP-CAR. METHODS: In a multi-institutional analysis, 626 DP-CARs were analysed retrospectively and compared with 1325 distal pancreatectomies undertaken in the same interval. RESULTS: Ninety-day mortality was observed in 7 of 21 high-volume centres (1 or more DP-CARs per year) and 1 of 41 low-volume centres (OR 20.00, 95 per cent c.i. 2.26 to 177.26). The incidence of ischaemic gastropathy was 19.2 per cent in the embolization group and 7.9 per cent in the no-embolization group (OR 2.77, 1.48 to 5.19). Propensity score matching analysis showed that median overall survival was 33.5 (95 per cent c.i. 27.4 to 42.0) months in the DP-CAR and 37.9 (32.8 to 53.3) months in the DP group. Multivariable analysis identified age at least 67 years (HR 1.40, 95 per cent c.i. 1.12 to 1.75), preoperative tumour size 30 mm or more (HR 1.42, 1.12 to 1.80), and preoperative carbohydrate antigen 19-9 level over 37 units/ml (HR 1.43, 1.11 to 1.83) as adverse prognostic factors. CONCLUSION: DP-CAR can be performed safely in centres for general pancreatic surgery regardless of DP-CAR volume, and preoperative embolization may not be required. This procedure has no oncological advantage for resectable tumour close to the bifurcation of the splenic artery, and should be performed after appropriate patient selection.

Clinical outcomes of organ-preserving pancreatectomy for benign or low-grade malignant pancreatic tumors: A multicenter nationwide survey in Japan.

BACKGROUND/PURPOSE: Whether organ-preserving pancreatic surgery has an advantage in postoperative short- and long-term outcomes or not is still unknown because only small case series studies have been available to date. In this multicenter retrospective study, we aimed to elucidate the clinical advantage and disadvantage of organ-preserving pancreatectomy among patients with low-grade malignant pancreatic tumors and benign pancreatic diseases. METHODS: We included patients diagnosed with benign or low-malignant pancreatic tumor who underwent pancreaticoduodenectomy (PD) in 621 cases, duodenum-preserving pancreatic head resection (DPPHR) in 31 cases, middle pancreatectomy (MP) in 148 cases, distal pancreatectomy (DP) in 814 cases, and spleen-preserving distal pancreatectomy (SPDP) in 259 cases between January 1, 2013, and December 31, 2017. Preoperative backgrounds, surgical outcomes and pre- and postoperative (3, 6, 12, 24, and 36 months) nutritional status were compared between these procedures. RESULTS: In terms of short-term outcomes, the incidence of pancreatic fistula in patients who underwent MP was significantly higher than in patients with standard pancreatectomy. As for the long-term pancreatic functions in the cases of head or body lesion, both exocrine and endocrine functions after MP were significantly favorable compared with the PD group from 3 to 36 months after surgery. In pancreatic body or tail lesion, significant advantage of endocrine function, but not exocrine function, was found in the MP group compared to standard DP at all time points. CONCLUSIONS: MP may contribute to the improvement of postoperative quality of life for patients with pancreatic body low-malignant tumors, rather than PD or DP; however, reducing the incidence of short-term complications such as pancreatic fistula is a future challenge.

Clinical Impact of Neoadjuvant Chemotherapy and Chemoradiotherapy in Borderline Resectable Pancreatic Cancer: Analysis of 884 Patients at Facilities Specializing in Pancreatic Surgery.

BACKGROUND: The efficacy of neoadjuvant therapy (NAT), including neoadjuvant chemotherapy (NAC) and neoadjuvant chemo-radiotherapy (NACRT), for patients with borderline resectable pancreatic cancer (BRPC) has not been elucidated. This study aimed to clarify the efficacy of NAC and NACRT for patients with BRPC. METHODS: The study analyzed the treatment outcomes of 884 patients treated for BRPC from 2011 to 2013. Treatment results were compared between upfront surgery and NAT and between NAC and NACRT using propensity score-matching analysis. Overall survival (OS) was calculated via intention-to-treat analyses. RESULTS: The overall resection rates for the patients who underwent NAT were significantly lower than for the patients who underwent upfront surgery (75.1% vs 93.3%; p < 0.001). However, the R0 resection rate was significantly higher for NAT than for upfront surgery (p < 0.001). Additionally, the OS for the patients who received NAT was significantly longer than for those who underwent upfront surgery (median survival time [MST], 25.7 vs 19.0 months; p = 0.015). The lymph node rate for the patients with NACRT was significantly lower than for those who underwent NAC (p < 0.001). However, the resection rate for the NACRT cases was significantly lower than for the NAC cases (p = 0.041). The local recurrence rate for the NACRT cases was significantly lower than for the NAC cases (p = 0.002). However, OS did not differ significantly between NAC and NACRT (MST, 29.2 vs 22.5 months; p = 0.130). CONCLUSIONS: The study showed that NAT has potential benefit for patients with BRPC. Compared with NAC, NACRT decreased the rates for lymph node metastasis and local recurrence but did not improve the prognosis.

Clinical features and treatment outcome of borderline resectable pancreatic head/body cancer: a multi-institutional survey by the Japanese Society of Pancreatic Surgery.

BACKGROUND: Optimal treatment types and prognosis for patients with borderline resectable pancreatic cancer (BRPC) remain unclear because of the lack of studies involving large series of patients. METHODS: We retrospectively analyzed various prognostic factors for 624 BRPC (pancreatic head/body) patients treated from June 2002 to May 2007, by distributing questionnaires to member institutions of the Japanese Society of Pancreatic Surgery in 2010. BRPC was defined according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2009). RESULTS: Among 624 patients, 539 (86.4 %) underwent curative-intent resection, showing an R0 resection rate of 65.9 %. The 3- and 5-year survival rates were 16.1 and 9.9 % in all patients, 22.8 and 12.5 % in the resected patients, and 4.4 and 0 % (P < 0.0001) in the unresected patients, respectively. The following factors influencing survival in all patients were selected as independent prognostic factors using multivariate analysis: major arterial involvement on imaging study; preoperative treatment; surgical resection; and postoperative chemotherapy. Among the resected cases, multivariate analysis revealed that major arterial involvement and remnant tumor status were independent prognostic factors. CONCLUSION: BRPC included two distinct categories of tumors influencing survival: those with portal vein/superior mesenteric vein invasion alone and those with major arterial invasion, which was the most exacerbating factor in the analysis.

Use of omentum or falciform ligament does not decrease complications after pancreaticoduodenectomy: nationwide survey of the Japanese Society of Pancreatic Surgery.

BACKGROUND: Wrapping is thought to prevent pancreatic fistula and postoperative hemorrhage for pancreaticoduodenectomy (PD), and we analyzed whether omentum/falciform ligament wrapping decreases postoperative complications after PD. METHODS: This is a retrospective study of wrapping using the omentum/falciform ligament in patients that underwent PD between January 2006 and June 2008 in 139 institutions that were members of the Japanese Society of Pancreatic Surgery. RESULTS: Ninety-one institutions responded to the questionnaires, and data were accumulated from 3,288 patients. The data from 2,597 patients were acceptable for analysis; 918 (35.3%) patients underwent wrapping and 1,679 patients did not. A pancreatic fistula occurred in 623 patients (37.3%) in the nonwrapping group, in comparison to 393 patients (42.8%) in the wrapping group (P = .006). The incidence of a grade B/C pancreatic fistula was lower in the nonwrapping group than the wrapping group (16.7% vs. 21.5%; P = .002). An intra-abdominal hemorrhage occurred in 54 patients (3.2%) in the nonwrapping group, which was similar to the incidence in the wrapping group (32 patients; 3.5%). The mortality was 1.3% and 1.0% in nonwrapping and wrapping groups, respectively. A multivariate analysis revealed 7 independent risk factors for pancreatic fistula; male, hypoalbuminemia, soft pancreas, long operation time, extended resection, pylorus preservation, and omentum wrapping. There were 4 independent risk factors for early intra-abdominal hemorrhage and 2 independent risk factors for late intra-abdominal hemorrhage. CONCLUSION: This retrospective study revealed that omentum wrapping did not decrease the incidence of pancreatic fistula. An additional validation study is necessary to evaluate the efficacy of wrapping for PD.

The effect of adjuvant and neoadjuvant chemo(radio)therapy on survival in 1,679 resected pancreatic carcinoma cases in Japan: report of the national survey in the 34th annual meeting of Japanese Society of Pancreatic Surgery.

BACKGROUND: Pancreatic carcinoma causes more than 20,000 deaths every year in Japan. The role of (neo-) adjuvant chemotherapy for pancreatic carcinoma is still controversial. METHODS: At the 34th Annual Meeting of the Japanese Society of Pancreatic Surgery in 2007, questionnaires were distributed regarding the use of (neo-) adjuvant chemo(radio)therapy for pancreatic carcinoma between 2001 and 2005. RESULTS: Sixty of the 146 member institutions responded to the questionnaires. There were a total of 1,846 cases of resected pancreatic carcinoma between 2001 and 2005. The study population had a greater proportion of males, and a mean age of 65.3 years (range 34-90 years). The lesion was located in the head of the pancreas in 1,204 cases (71.7%), in the body in 353 cases (21.0%), and in the tail in 111 cases (6.6%). Overall survival rates were 67.3% at 1 year, 36.0% at 2 years, and 23.9% at 3 years, respectively. Adjuvant chemotherapy (usually involving gemcitabine) was used in 66.0% of cases. The use of adjuvant chemotherapy was found to improve the overall survival rate. Interestingly, adjuvant chemotherapy only improved survival in late-stage (UICC stages IIB, III, and IV) but not early stage (IA, IB, and IIA) patients. Survival was treatment duration-dependent, with patients who received more than 12 months of therapy having a 3-year survival rate of 51.2%. CONCLUSION: This high volume retrospective data indicated the promising effect of gemcitabine-based adjuvant chemotherapy and the rational duration of adjuvant chemotherapy should be determined in the future prospective studies.

Biliary tract cancer treatment: 5,584 results from the Biliary Tract Cancer Statistics Registry from 1998 to 2004 in Japan.

BACKGROUND/PURPOSE: The results from the Japanese Biliary Tract Cancer Statistics Registry from 1988 to 1998 were reported in 2002. In the present study, we report here selectively summarized data as an overview of the 2006 follow-up survey of the registered cases from 1998 to 2004 for information bearing on problems with the treatment of cancer of the biliary tract. METHODS: A total of 5,584 patients were registered from 1998 to 2004. The site of cancer was the bile duct in 2,732 patients, the gallbladder in 2,067, and the papilla of Vater in 785. Those cases were analyzed with regard to patient survival according to the extent of tumor invasion (pT), the extent of lymph node metastasis (pN) and the stage. RESULTS: The five-year survival rate after surgical resection was 33.1% for bile duct cancer, 41.6% for gallbladder cancer, and 52.8% for cancer of the papilla of Vater. For hilar or superior bile duct cancer, the 5-year survival rate was lower with an increase in the pT, pN and f stage, except pT3 vs. pT4, pN1 vs. pN2 and stage III vs. stage IVa. For middle or distal bile duct cancer, the 5-year survival rate was lower with increase in pT, pN and f stage, except pT2 vs. pT3, pN2 vs. pN3, stage II vs. stage III and stage III vs. stage IVa. For gallbladder cancer, the 5-year survival rate was lower with increase in pT, pN and f stage. For cancer of the papilla of Vater, the 5-year survival rate was lower with increase in pT, pN and f stage, except pT1 vs. pT2, pN1 vs. pN2, and stage III vs. stage IVa. CONCLUSIONS: In the present study, the outcomes of surgical treatment were better than that of the previous report from Japan and foreign countries. The pT, pN and stage of gallbladder cancer are well defined. However, there were no significant differences in some groups of those of bile duct cancer and cancer of the papilla of Vater.

Prognostic factors for gallbladder cancer in Japan.

OBJECTIVE: The objective of this study was to evaluate prognostic predictors for patients with gallbladder cancer (GBC) in a Japanese nationwide data base. SUMMARY BACKGROUND DATA: GBC is the most common cancer of the biliary tract in Japan. Differences in the survival rates between Japan and other countries have been noted. METHODS: The authors analyzed 4424 patients with GBC in Japan between 1988 and 1997. Staging was determined in accordance with American Joint Committee on Cancer stage. RESULTS: Survival is related closely to the surgical stage. Five-year survival rates for stage I, II, III, IVA, and IVB (5th edition) were 83%, 70%, 45%, 23%, and 9%, respectively. These differences were significant (P < 0.0001). The survival rate for patients aged <60 years was significantly better (P < 0.05). The survival rate for patients aged >69 years was significantly worse (P < 0.01). The cholecystectomy plus combined resection of bile duct and/or liver bed resection had an effect on prolonging the survival in stage II or III disease, but extended resection did not. The patients with anomalous pancreaticobiliary ductal junction had a survival advantage over those with cholelithiasis by univariate analysis. However, multivariate analyses indicated that only age, sex, stage, operative procedures were independent prognostic factors. Stage was the strongest covariate; patients diagnosed with stage II, III, IVA, or IVB disease were 2.2, 4.2, 8.1, and 13.6 times, respectively, were more likely to die. CONCLUSIONS: Staging is the strongest prognostic factor for GBC, but patient outcomes were also affected by age, sex, and operative procedures. The data do not support any advantage for extended resection. Neither gallstones nor anomalous pancreaticobiliary ductal junction influenced the GBC patient outcome.

Recent trends of gallbladder cancer in Japan: an analysis of 4,770 patients.

BACKGROUND: Gallbladder cancer is the most common cancer of the biliary tract and has a particularly high incidence in Chile, Japan, and northern India. Many Japanese surgeons have reported that aggressive surgery improves the outcome of patients with gallbladder cancer. Differences in survival rates between Japan and other countries have been noted. The objective of this study was to determine whether there were any changes over time in the incidence, therapeutic approach, stage at diagnosis, or prognosis of gallbladder cancer in an unselected, community-based series of patients in Japan. METHODS: In total, 4,774 patients with gallbladder cancer were analyzed between 1988 and 1997 based on data from the Biliary Tract Cancer Registration Committee of the Japanese Society of Biliary Surgery. RESULTS: Survival was related closely to surgical stage, with 5-year survival rates of 77% for patients with stage I disease, 60% for patients with stage II disease, 29% for patients with stage III disease, 12% for patients with stage IVA disease, and 3% for patients with stage IVB disease. Patient age also affected survival. The survival rate for patients aged <49 years was significantly better compared with the survival rate for patients in the other groups (P < .05). The 5-year survival rate for patients aged <49 years was 38%. The survival rate for patients aged >79 years was significantly worse compared with the survival rate for patients in the other 4 groups (P < .01). The 5-year survival rate for patients aged >79 years was 21%. Stratifying patients by stage according to the Japanese Society of Biliary Surgery classification showed that women maintained a survival advantage over men among patients with stage I and II disease. Adjuvant chemotherapy did not provide a survival benefit. There were no apparent changes in patient demographics between the period from 1988 to 1992 and the period from 1993 to 1997. CONCLUSIONS: For this study, the authors evaluated the gallbladder cancer trends in Japan. The Classification of Biliary Tract Carcinoma proposed by the Japanese Society of Biliary Surgery reflected the prognosis of patients with gallbladder cancer. Patient outcomes were affected by patient age and sex. No substantial differences in patient survival were apparent over the 10-year study period. The data did not support any advantage for aggressive surgical resection and adjuvant chemotherapy. Further analysis of operative procedures will be necessary to determine conclusively whether there is any survival advantage from aggressive surgery in patients with advanced gallbladder cancer.

Status of surgical treatment of biliary tract cancer.

Complete surgical resection of biliary tract carcinoma remains the best treatment. The Japanese Society of Biliary Surgery has organized a registry project and established a classification of biliary tract carcinoma. We report here the status of biliary surgery in Japan. For hilar bile duct carcinoma, major hepatectomy is needed to increase the resection rate, and total caudate lobectomy is required for curative resection. The 5-year survival rate was 39.1%. Middle and distal bile duct carcinomas were treated with pancreatoduodenectomy (PD) or pylorus-preserving PD (PPPD) or bile duct resection alone. The 5-year survival rate was 44.0%. The treatment of gallbladder carcinoma with pT1 lesions is cholecystectomy. The treatment of pT2 lesions is extended cholecystectomy or various hepatectomy with or without extrahepatic bile duct resection along with lymphadenectomy. Treatment of pT3 and pT4 lesions includes hepatectomy with or without bile duct resection, combined with vascular resection, extended lymphadenectomy, and autonomic nerve dissection. Several groups in Japan have performed hepatopancreatoduodenectomy. The 5-year survival rate of pT1, pT2, pT3, and pT4 were 93.7, 65.1, 27.3, and 13.8%. PD or PPPD is the standard operation for carcinoma of the papilla of Vater. The 5-year survival rate was 57.5%.

The selection of pancreatic reconstruction techniques gives rise to higher incidences of morbidity: results of the 30th Japan Pancreatic Surgery Questionnaire Survey on pancreatoduodenectomy in Japan.

BACKGROUND/PURPOSE: We aimed to determine the impact of the surgical strategy used for pancreatic reconstruction on morbidity after pancreatoduodenectomy (PD). METHODS: A questionnaire was sent to all surgeon members of the Japan Pancreatic Surgery Club in December 2002. RESULTS: We received 152 replies, and the data from all of them were used in the analysis. Thirty-six percent of the 152 responders performed PD and selected from among two or more pancreatic reconstruction techniques (PRTs). PRT selection was used no more frequently in the high- and medium-hospital-volume institutions than in low-hospital-volume institutions (25% or 37% vs 35%). The incidence of both "all arterial hemorrhage" and "delayed arterial hemorrhage" after PD in the institutions that used multiple PRTs was significantly higher than that in the institutions where only a single PRT was used (4.2% vs 2.2%, and 3.3% vs 1.5%, respectively; P < 0.05). In the high- and medium-hospital-volume institutions, the incidence of all arterial hemorrhage after PD in the multiple-PRT institutions was significantly higher than that in the single-PRT institutions (4.0% vs 1.9%; P < 0.05). Furthermore, in the low-hospital-volume institutions, the incidence of delayed arterial hemorrhage, 7 or more days after PD, was clearly higher in the multiple-PRT institutions than in the single-PRT institutions (4.1% vs 1.4%; P = 0.056). Therefore, the hospital-case volumes of PD were distributed as practice-case volumes according to the PRT by the selection of PRTs, and PRT selection gave rise to higher incidences of morbidity as a result of pancreatic leakage after PD. CONCLUSIONS: The hospital-case-volume - better outcome relation for PD was attributable to expert pancreatic reconstruction skills that can be mastered only through frequent repetition.

Long-term survivors after resection of carcinoma of the head of the pancreas: significance of histologically curative resection.

BACKGROUND/PURPOSE: The prognosis of patients with pancreatic cancer is said to have not been improved markedly by any procedures in the past 20 years. Since 1973, we have gradually extended the area of dissection when performing curative resection for pancreatic cancer to improve the resection rate and prognosis. Nineteen patients have survived for 3 years or more, and the 5-year survival rates of patients with cancer of the head of the pancreas were 23.9% for macroscopically curative resection and 34.3% for histologically curative resection. METHODS: We histologically observed surgical specimens, cut into 3- to 5-mm sections and compared the histologic characteristics of the 19 patients who survived for 3 years or more with those of 41 patients who died of cancer within 3 years (excluding 6 operative and hospital deaths), in order to find the conditions required for long-term survival. RESULTS: The following conditions were associated with long-term survival: (1) tumor diameter 3 cm or less; (2) either absence of lymph node metastasis or metastasis limited to the n(1) group; (3) degree of invasion of the anterior pancreatic capsule of zero (s0); and (4) either no retropancreatic invasion (rp0) or exposed retropancreatic invasion (rpe) with no cancer invasion of dissected peripancreatic tissue ew(-). CONCLUSIONS: At present, because the rpe rate is more than 70%, resection of the pancreas, including the superior mesenteric vein and the retropancreatic fusion fascia, is essential for a curative resection, because the retropancreatic tissue between the back of the pancreas and this fascia is anatomically considered to be in the position of the subserosal tissue in the gallbladder or stomach. Combined resection of the superior mesenteric artery may further improve the results of resection for pancreatic cancer, from the anatomical viewpoint.

Current pancreatogastrointestinal anastomotic methods: results of a Japanese survey of 3109 patients.

BACKGROUND: Pancreatogastrointestinal anastomosis is the most important anastomotic method of reconstructing the digestive tract following pancreaticoduodenectomy. METHODS: We therefore conducted a survey on pancreatogastrointestinal anastomosis at the 28th Japan Pancreatic Surgery Club in 2001. RESULTS: Results revealed that of the methods of pancreatogastrointestinal anastomosis, pancreatojejunostomy (82.9%) was overwhelmingly more popular than pancreatogastrostomy (17.1%). Anastomotic leakage occurred in 12.8% of cases, and 13.0% of these patients died. The incidence of anastomotic leakage was 11.0% with pancreatogastrostomy, and 13.3% with pancreatojejunostomy. There was no significant difference in the development of anastomotic leakage among the anastomotic organ used with the pancreas, the pancreas resection method, and the pancreatic juice drainage method. Investigation of intra-abdominal hemorrhage and abscess, which are serious complications that result from anastomotic leakage, revealed that intra-abdominal hemorrhage occurred in 1.1% of all cases, and intra-abdominal abscess was seen in 3.3% of all cases. However, there were no significant differences between pancreatogastrostomy and pancreatojejunostomy with respect to incidence rates of intra-abdominal hemorrhage and abscess or mortality. CONCLUSIONS: The method of pancreatogastrointestinal anastomosis should be chosen according to each individual case.

Is postoperative adjuvant chemotherapy useful for gallbladder carcinoma? A phase III multicenter prospective randomized controlled trial in patients with resected pancreaticobiliary carcinoma.

BACKGROUND: To the authors' knowledge, the significance of postoperative adjuvant chemotherapy in pancreaticobiliary carcinoma has not yet been clarified. A randomized controlled study evaluated the effect of postoperative adjuvant therapy with mitomycin C (MMC) and 5-fluorouracil (5-FU) (MF arm) versus surgery alone (control arm) on survival and disease-free survival (DFS) for each specific disease comprising resected pancreaticobiliary carcinoma (pancreatic, gallbladder, bile duct, or ampulla of Vater carcinoma) separately. METHODS: Between April 1986 and June 1992, a total of 508 patients with resected pancreatic (n = 173), bile duct (n = 139), gallbladder (n = 140), or ampulla of Vater (n = 56) carcinomas were allocated randomly to either the MF group or the control group. The MF group received MMC (6 mg/m(2) intravenously [i.v.]) at the time of surgery and 5-FU (310 mg/m(2) i.v.) in 2 courses of treatment for 5 consecutive days during postoperative Weeks 1 and 3, followed by 5-FU (100 mg/m(2)orally) daily from postoperative Week 5 until disease recurrence. All patients were followed for 5 years. RESULTS: After ineligible patients were excluded, 158 patients with pancreatic carcinoma (81 in the MF group and 77 in the control group), 118 patients with bile duct carcinoma (58 in the MF group and 60 in the control group), 112 patients with gallbladder carcinoma (69 in the MF group and 43 in the control group), and 48 patients with carcinoma of the ampulla of Vater (24 in the MF group and 24 in the control group) were evaluated. Good compliance (> 80%) was achieved with MF treatment. The 5-year survival rate in gallbladder carcinoma patients was significantly better in the MF group (26.0%) compared with the control group (14.4%) (P = 0.0367). Similarly, the 5-year DFS rate of patients with gallbladder carcinoma was 20.3% in the MF group, which was significantly higher than the 11.6% DFS rate reported in the control group (P = 0.0210). Significant improvement in body weight compared with the control was observed only in patients with gallbladder carcinoma. There were no apparent differences in 5-year survival and 5-year DFS rates between patients with pancreatic, bile duct, or ampulla of Vater carcinomas. Multivariate analyses demonstrated a tendency for the MF group to have a lower risk of mortality (risk ratio of 0.654; P = 0.0825) and recurrence (risk ratio of 0.626; P = 0.0589). The most commonly reported adverse drug reactions were anorexia, nausea/emesis, stomatitis, and leukopenia, none of which were noted to be serious. CONCLUSIONS: The results of the current study indicate that gallbladder carcinoma patients who undergo noncurative resections may derive some benefit from systemic chemotherapy. However, alternative modalities must be developed for patients with carcinomas of the pancreas, bile duct, or ampulla of Vater.

Biliary tract cancer treatment: results from the Biliary Tract Cancer Statistics Registry in Japan.

BACKGROUND/PURPOSE: A registry project for cancers of the biliary tract accumulated a total of 11,030 cases for 10 years. In the present study, registered cases were analyzed for information bearing on problems with the treatment of cancer of the biliary tract. The Japanese classification of lymph nodes was also considered on the basis of the results of this study. METHODS: In 11,030 cases, the site of cancer was the gallbladder in 4,774, the bile duct in 4,833, and the papilla of Vater in 1,423. Those cases were analyzed with regard to patient survival according to the stage of disease and the extent of lymph node metastasis. RESULTS: More than 11,000 cases of cancer of the biliary tract have been registered to date from 158 member institutions of the Japanese Society of Biliary Surgery. While the 5-year survival rates for stage I gallbladder cancer and cancer of the papilla were 77% and 75%, respectively, those for stage I hilar or upper bile duct cancer and middle or lower bile duct cancer were 47% and 54%. For stage II and stage III disease, the 5-year survival rates were about 50% for gallbladder cancer and 30% or higher for cancer of the papilla, while survival was only 20% to 30% for bile duct cancer, regardless of specific site. For stage IV, the 5-year survival rate was unexpectedly high, being about 10% or higher for cancers at all sites, with 19% for cancer of the papillary region being the highest. Thus, there still seem to remain surgical indications for stage IV cancers. The lymph node metastasis rate was about 40% for cancers at all sites. Changes in surgical procedures to improve the 5-year survival rate in patients with n2 metastasis or less will be needed. Noncurative resection occurred frequently for cancers at all sites, particularly in cancers of the hilar or upper bile duct, accounting for 60% of cases or more. We have to recognize that measures to reduce inadvertent noncurative resection are fundamental to the treatment of cancer. CONCLUSIONS: Considering the survival results according to specific lymph nodes involved, we concluded that the Japanese classification of lymph nodes, particularly hepatoduodenal ligament lymph nodes, should be reexamined, while another procedure to remove such lymph nodes completely should be developed.