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Background In 2005, the International Study Group of Pancreatic Fistula developed a definition and grading of postoperative pancreatic fistula that has been accepted universally. Eleven years later, because postoperative pancreatic fistula remains one of the most relevant and harmful complications of pancreatic operation, the International Study Group of Pancreatic Fistula classification has become the gold standard in defining postoperative pancreatic fistula in clinical practice. The aim of the present report is to verify the value of the International Study Group of Pancreatic Fistula definition and grading of postoperative pancreatic fistula and to update the International Study Group of Pancreatic Fistula classification in light of recent evidence that has emerged, as well as to address the lingering controversies about the original definition and grading of postoperative pancreatic fistula. Methods The International Study Group of Pancreatic Fistula reconvened as the International Study Group in Pancreatic Surgery in order to perform a review of the recent literature and consequently to update and revise the grading system of postoperative pancreatic fistula. Results Based on the literature since 2005 investigating the validity and clinical use of the original International Study Group of Pancreatic Fistula classification, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula. Consequently, the former “grade A postoperative pancreatic fistula” is now redefined and called a “biochemical leak,” because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place >3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula. Conclusion This new definition and grading system of postoperative pancreatic fistula should lead to a more universally consistent evaluation of operative outcomes after pancreatic operation and will allow for a better comparison of techniques used to mitigate the rate and clinical impact of a pancreatic fistula. Use of this updated classification will also allow for more precise comparisons of surgical quality between surgeons and units who perform pancreatic surgery.

Background Recent literature suggests that chyle leak may complicate up to 10% of pancreatic resections. Treatment depends on its severity, which may include chylous ascites. No international consensus definition or grading system of chyle leak currently is available. Methods The International Study Group on Pancreatic Surgery, an international panel of pancreatic surgeons working in well-known, high-volume centers, reviewed the literature and worked together to establish a consensus on the definition and classification of chyle leak after pancreatic operation. Results Chyle leak was defined as output of milky-colored fluid from a drain, drain site, or wound on or after postoperative day 3, with a triglyceride content ≥110 mg/dL (≥1.2 mmol/L). Three different grades of severity were defined according to the management needed: grade A, no specific intervention other than oral dietary restrictions; grade B, prolongation of hospital stay, nasoenteral nutrition with dietary restriction, total parenteral nutrition, octreotide, maintenance of surgical drains, or placement of new percutaneous drains; and grade C, need for other more invasive in-hospital treatment, intensive care unit admission, or mortality. Conclusion This classification and grading system for chyle leak after pancreatic resection allows for comparison of outcomes between series. As with the other the International Study Group on Pancreatic Surgery consensus statements, this classification should facilitate communication and evaluation of different approaches to the prevention and treatment of this complication.

Background The lymph node (Ln) status of patients with resectable pancreatic ductal adenocarcinoma is an important predictor of survival. The survival benefit of extended lymphadenectomy during pancreatectomy is, however, disputed, and there is no true definition of the optimal extent of the lymphadenectomy. The aim of this study was to formulate a definition for standard lymphadenectomy during pancreatectomy. Methods During a consensus meeting of the International Study Group on Pancreatic Surgery, pancreatic surgeons formulated a consensus statement based on available literature and their experience. Results The nomenclature of the Japanese Pancreas Society was accepted by all participants. Extended lymphadenectomy during pancreatoduodenectomy with resection of Ln's along the left side of the superior mesenteric artery (SMA) and around the celiac trunk, splenic artery, or left gastric artery showed no survival benefit compared with a standard lymphadenectomy. No level I evidence was available on prognostic impact of positive para-aortic Ln's. Consensus was reached on selectively removing suspected Ln's outside the resection area for frozen section. No consensus was reached on continuing or terminating resection in cases where these nodes were positive. Conclusion Extended lymphadenectomy cannot be recommended. Standard lymphadenectomy for pancreatoduodenectomy should strive to resect Ln stations no. 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. For cancers of the body and tail of the pancreas, removal of stations 10, 11, and 18 is standard. Furthermore, lymphadenectomy is important for adequate nodal staging. Both pancreatic resection in relatively fit patients or nonresectional palliative treatment were accepted as acceptable treatment in cases of positive Ln's outside the resection plane. This consensus statement could serve as a guide for surgeons and researchers in future directives and new clinical studies.

Background Delayed gastric emptying (DGE) is one of the most common complications after pancreatic resection. In the literature, the reported incidence of DGE after pancreatic surgery varies considerably between different surgical centers, primarily because an internationally accepted consensus definition of DGE is not available. Several surgical centers use a different definition of DGE. Hence, a valid comparison of different study reports and operative techniques is not possible. Methods After a literature review on DGE after pancreatic resection, the International Study Group of Pancreatic Surgery (ISGPS) developed an objective and generally applicable definition with grades of DGE based primarily on severity and clinical impact. Results DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) were defined based on the impact on the clinical course and on postoperative management. Conclusion The proposed definition, which includes a clinical grading of DGE, should allow objective and accurate comparison of the results of future clinical trials and will facilitate the objective evaluation of novel interventions and surgical modalities in the field of pancreatic surgery.

Background Postoperative pancreatic fistula (POPF) is still regarded as a major complication. The incidence of POPF varies greatly in different reports, depending on the definition applied at each surgical center. Our aim was to agree upon an objective and internationally accepted definition to allow comparison of different surgical experiences. Methods An international panel of pancreatic surgeons, working in well-known, high-volume centers, reviewed the literature on the topic and worked together to develop a simple, objective, reliable, and easy-to-apply definition of POPF, graded primarily on clinical impact. Results A POPF represents a failure of healing/sealing of a pancreatic-enteric anastomosis or a parenchymal leak not directly related to an anastomosis. An all-inclusive definition is a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of POPF (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. Conclusions The present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when new techniques, new operations, or new pharmacologic agents that may impact surgical treatment of pancreatic disorders are addressed.

Objective: We investigated the role of drainage in the prevention of complications after elective rectal or anal anastomosis in the pelvis. Anastomotic leakage after colorectal resection is more prevalent when the anastomosis is in the distal or infraperitoneal pelvis than in the abdomen. The benefit of pelvic drains versus their potential harm has been questioned. Drain-related complications include (1) those possibly benefiting from drainage (leakage, intra-abdominal infection, bleeding) and (2) those possibly caused by drainage (wound infection or hernia, intestinal obstruction, fistula). Methods: Between September 1990 and June 1995, 494 patients (249 men and 245 women), mean age 66 ± 15 (range 15 to 101) years, with either carcinoma, benign tumor, colonic Crohn's disease, diverticular disease of the sigmoid colon, or another disorder located anywhere from the right colon to the midrectum undergoing resection followed by rectal or anal anastomosis were randomized to undergo either drainage (n = 248) with 2 multiperforated 14F suction drains or no drainage (n = 246). The primary end point was the number of patients with one or more postoperative drain-related complications. Secondary end points included severity of these complications as assessed by the rate of related repeat operations and associated deaths as well as extra-abdominally related morbidity and mortality. Results: After withdrawal of 2 patients (1 in each group) both groups were comparable with regard to preoperative characteristics and intraoperative findings. The overall leakage rate was 6.3% with no significant difference between those with or without drainage. There were 18 deaths (3.6%), 8 (3.2%) in those with drainage and 10 (4%) in those without drainage. Five patients with anastomotic leakage died (1%), 3 of whom had drainage. There were 32 repeat operations (6.5%) for anastomotic leakage 11 in the group with drainage and 4 in the group with no drainage. The rate of these and the other intra-abdominal and extra-abdominal complications did not differ significantly between the 2 groups. Conclusion: Prophylactic drainage of the pelvic space does not improve outcome or influence the severity of complications. (Surgery 1999;125:529-35.)

Background: In patients with symptomatic cholelithiasis, preoperative diagnosis of common bile duct (CBD) stones can modify the therapeutic strategy. The aims of this prospective, controlled multicenter study were to assess the feasibility, concordance, discordance, and indexes such as sensitivity, specificity, positive and negative predictive values, and accuracy of preoperative endoscopic ultrasonography compared with those of intraoperative cholangiography (IOC) in the diagnosis of asymptomatic CBD stones (i.e., patients undergoing cholecystectomy with no clinical or biologic evidence of CBD stones). Methods: From October 1993 to October 1995, 240 consecutive patients with symptomatic cholelithiasis, scheduled for cholecystectomy in 14 surgical centers, were enrolled in this study. All patients were selected for this study according to a preoperative high-risk CBD stone predictive score. Each patient underwent both endoscopic ultrasonography and IOC, as well as surgical exploration of the CBD when stones were detected during one or both preoperative investigations. All patients were seen 1 month and 1 year after operation to check for residual stones. Results: The feasibility of endoscopic ultrasonography was significantly higher overall than that of IOC (99% vs 90%; p

Background Mechanical anastomosis has been claimed to reduce the rate of leakage compared with manual anastomosis. No randomized trials have been performed to date to prove this specifically in esophagogastric anastomosis. Methods. One hundred fifty-four patients, 139 men and 15 women ranging in age from 36 to 83 years (mean, 50±10 years) and undergoing elective resection of esophageal or cardial carcinoma, were included in this multiinstitutional (14 centers) randomized study comparing the rate of anastomotic leakage after esophagogastric anastomosis performed manually or mechanically. Eligible for this study were patients with esophageal or cardial carcinoma located between the esophagogastric junction (included) and the upper border of the aortic arch. The choice between resection with or without thoractomy was left to the discretion of the operating surgeon. Proximal resection of the fundus was mandatory. Intestinal tract continuity was reestablished in a one-stage procedure by an esophagogastric anastomosis without interposition of either the jejunum or the colon. The site of the anastomosis could be either intrathoracic or cervical. The principal end point was anastomotic leakage as judged by (1) egress of intestinal fluids or orally ingested methylene blue through drains, (2) sodium diatrozate swallow prescribed either routinely for all patients between postoperative days 3 and 8 or because of signs of leakage, or (3) reoperation or autopsy. Results. After two patients were withdrauwn for protocol violation, 152 patients, 74 in the manual group and 78 in the mechanical group, were studied. The number of anastomotic leakages was identical in both groups (n=12, 16% and 15%, respectively). Overall 30-day mortality was 11%. Fewer deaths occurred in the manual group (7%), which had three anastomotic leakages, than in the mechanical group (15%), which had five anastomotic leakages, and fewer repeat operations were done in the manual group (n=9) than in the mechanical group (n=13), but both of these differences were not statistically significant. The duration of anastomosis and of operation was similar in both groups. In the mechanical group 16 anastomoses (20%) gave rise to technical mishaps (either in the fashioning of the purse-string, dilation of the esophagus, or in stapling). Among the factors recognized as potentially preventing leakage, only testing for airtightness was significantly correlated with less postoperative leakage (p Conclusions. When mechanical staples rather than manual sutures are chosen, the disadvantages (technical mishaps and higher costs) are not counterbalanced by a gain of time or a decrease in the rate or severity of anastomotic leakage.

Background Although used widely for supraperitoneal anastomoses, circular stapled anastomoses have never been proved better than hand-sewn anastomoses. In the one prospective controlled trial that studied these anastomoses specifically, the only significant difference found was that there were more clinically obvious leakages with the circular stapled variety, but not in the overall clinical and roentgenologic leakage rates. Methods. One hundred fifty-nine consecutive patients (88 men and 71 women, mean age 65.8±12.1years) were randomized to undergo hand-sewn (n=74) or circular stapled (n=85) supraperitoneal colorectal anastomosis after left colectomy. Results. Patient demographics were similar in both groups. Overall mortality was 1.3% (2 of 159; one in each group). No statistically significant difference (NS) was found in the rate of early complications, including anastomotic leakage (4 of 74 versus 6 of 85) in the hand-sewn and stapled anastomoses, respectively). Mishaps (n=10) and hemorrhage (n=5) occurred in the stapled group only. Stapled anastomoses took an average of 8 minutes less to perform (p Conclusions. According to these results, there seems to be no advantage of routine or regular use of stapling instruments for supraperitoneal colorectal anastomosis.

Background Postoperative hemorrhage is one of the most severe complications after pancreatic surgery. Due to the lack of an internationally accepted, universal definition of postpancreatectomy hemorrhage (PPH), the incidences reported in the literature vary considerably, even in reports from randomized controlled trials. Because of these variations in the definition of what constitutes a PPH, the incidences of its occurrence are not comparable. Methods The International Study Group of Pancreatic Surgery (ISGPS) developed an objective, generally applicable definition of PPH based on a literature review and consensus clinical experience. Results Postpancreatectomy hemorrhage is defined by 3 parameters: onset, location, and severity. The onset is either early (≤24 hours after the end of the index operation) or late (>24 hours). The location is either intraluminal or extraluminal. The severity of bleeding may be either mild or severe. Three different grades of PPH (grades A, B, and C) are defined according to the time of onset, site of bleeding, severity, and clinical impact. Conclusions An objective, universally accepted definition and clinical grading of PPH is important for the appropriate management and use of interventions in PPH. Such a definition also would allow comparisons of results from future clinical trials. Such standardized definitions are necessary to compare, in a nonpartisan manner, the outcomes of studies and the evaluation of novel operative treatment modalities in pancreatic surgery.

Background Studies of risk factors after pancreatoduodenectomy are few: some concern restricted populations and others are based on administrative data. Methods Multicenter clinical data were collected for 300 patients undergoing pancreatoduodenectomy to determine (by univariate and multivariate analysis) preoperative and intraoperative risk factors for mortality and intra-abdominal complications (IACs), including pancreatic fistula. Fourteen factors including the center and volume effect were analyzed. Results In univariate analysis, mortality was increased with age 70 years or more, extended resection(s), and volume and center effects. IACs occurred more often with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, extended resection(s), and the center effect. Pancreatic fistula was more frequent with main pancreatic duct diameter of 3 mm or less, normal parenchyma texture, and the center effect. In multivariate analysis, independent risk factor(s) for mortality were age greater than 70 years (odds ratio [OR], 3; 95% confidence interval [CI], 1.3-8) and extended resection (OR, 5; 95% CI, 1.2-22), risk factors for IACs were extended resection (OR, 5; 95% CI, 1.2-22) and main pancreatic duct diameter of 3 mm or less (OR, 2; 95% CI, 1.1-3), and the risk factor for pancreatic fistula was main pancreatic duct diameter of 3 mm or less (OR, 2.5; 95% CI, 1.2-4.6). Conclusions Age more than 70 years, extended resections, and main pancreatic duct diameter less than 3 mm are independent risk factors that should be considered in indications for and techniques of pancreatoduodenectomy.

We investigated the role of drainage in the prevention of complications after elective rectal or anal anastomosis in the pelvis. Anastomotic leakage after colorectal resection is more prevalent when the anastomosis is in the distal or infraperitoneal pelvis than in the abdomen. The benefit of pelvic drains versus their potential harm has been questioned. Drain-related complications include (1) those possibly benefiting from drainage (leakage, intra-abdominal infection, bleeding) and (2) those possibly caused by drainage (wound infection or hernia, intestinal obstruction, fistula).Between September 1990 and June 1995, 494 patients (249 men and 245 women), mean age 66 +/- 15 (range 15 to 101) years, with either carcinoma, benign tumor, colonic Crohn's disease, diverticular disease of the sigmoid colon, or another disorder located anywhere from the right colon to the midrectum undergoing resection followed by rectal or anal anastomosis were randomized to undergo either drainage (n = 248) with 2 multiperforated 14F suction drains or no drainage (n = 246). The primary end point was the number of patients with one or more postoperative drain-related complications. Secondary end points included severity of these complications as assessed by the rate of related repeat operations and associated deaths as well as extra-abdominally related morbidity and mortality.After withdrawal of 2 patients (1 in each group) both groups were comparable with regard to preoperative characteristics and intraoperative findings. The overall leakage rate was 6.3% with no significant difference between those with or without drainage. There were 18 deaths (3.6%), 8 (3.2%) in those with drainage and 10 (4%) in those without drainage. Five patients with anastomotic leakage died (1%), 3 of whom had drainage. There were 32 repeat operations (6.5%) for anastomotic leakage 11 in the group with drainage and 4 in the group with no drainage. The rate of these and the other intra-abdominal and extra-abdominal complications did not differ significantly between the 2 groups.Prophylactic drainage of the pelvic space does not improve outcome or influence the severity of complications.

In patients with symptomatic cholelithiasis, preoperative diagnosis of common bile duct (CBD) stones can modify the therapeutic strategy. The aims of this prospective, controlled multicenter study were to assess the feasibility, concordance, discordance, and indexes such as sensitivity, specificity, positive and negative predictive values, and accuracy of preoperative endoscopic ultrasonography compared with those of intraoperative cholangiography (IOC) in the diagnosis of asymptomatic CBD stones (i.e., patients undergoing cholecystectomy with no clinical or biologic evidence of CBD stones).From October 1993 to October 1995, 240 consecutive patients with symptomatic cholelithiasis, scheduled for cholecystectomy in 14 surgical centers, were enrolled in this study. All patients were selected for this study according to a preoperative high-risk CBD stone predictive score. Each patient underwent both endoscopic ultrasonography and IOC, as well as surgical exploration of the CBD when stones were detected during one or both preoperative investigations. All patients were seen 1 months and 1 year after operation to check for residual stones.The feasibility of endoscopic ultrasonography was significantly higher overall than that of IOC (99% vs 90%; p0.001), except when IOC was through a laparotomy (97% vs 93%; p = 0.16). The number of patients available for study was 215. In 198 cases (92%), results of both investigations were in concordance (161 negative and 37 positive values). Seventeen cases (8%) were discordant. There was overall concordance between the two investigations (kappa coefficient 0.764; 95% confidence interval 0.66 to 0.87), but the percentage of discordance was in favor of IOC. Sensitivity and specificity of IOC were significantly higher than those of endoscopic ultrasonography (1.00 and 0.98 vs 0.85 and 0.93, respectively). With a prevalence of CBD stones of 19%, positive and negative predictive values of IOC were significantly higher than those of endoscopic ultrasonography (0.93 and 1.00 vs 0.75 and 0.96, respectively).Although endoscopic ultrasonography is feasible more often than IOC, IOC is associated with a slightly lower degree of discordance and better information indexes and remains an efficient method of investigation for CBD stones. Endoscopic ultrasonography can be suggested in preference to endoscopic retrograde cholangiography when postoperative residual stones are suspected but need not be performed routinely before cholecystectomy.

Mechanical anastomosis has been claimed to reduce the rate of leakage compared with manual anastomosis. No randomized trials have been performed to date to prove this specifically in esophagogastric anastomosis.One hundred fifty-four patients, 139 men and 15 women ranging in age from 36 to 83 years (mean, 50 +/- 10 years) and undergoing elective resection of esophageal or cardial carcinoma, were included in this multiinstitutional (14 centers) randomized study comparing the rate of anastomotic leakage after esophagogastric anastomosis performed manually or mechanically. Eligible for this study were patients with esophageal or cardial carcinoma located between the esophagogastric junction (included) and the upper border of the aortic arch. The choice between resection with or without thoracotomy was left to the discretion of the operating surgeon. Proximal resection of the fundus was mandatory. Intestinal tract continuity was reestablished in a one-stage procedure by an esophagogastric anastomosis without interposition of either the jejunum or the colon. The site of the anastomosis could be either intrathoracic or cervical. The principal end point was anastomotic leakage as judged by (1) egress of intestinal fluids or orally ingested methylene blue through drains, (2) sodium diatrozate swallow prescribed either routinely for all patients between postoperative days 3 and 8 or because of signs of leakage, or (3) reoperation or autopsy.After two patients were withdrawn for protocol violation, 152 patients, 74 in the manual group and 78 in the mechanical group, were studied. The number of anastomotic leakages was identical in both groups (n = 12, 16% and 15%, respectively). Overall 30-day mortality was 11%. Fewer deaths occurred in the manual group (7%), which had three anastomotic leakages, than in the mechanical group (15%), which had five anastomotic leakages, and fewer repeat operations were done in the manual group (n = 9) than in the mechanical group (n = 13), but both of these differences were not statistically significant. The duration of anastomosis and of operation was similar in both groups. In the mechanical group 16 anastomoses (20%) gave rise to technical mishaps (either in the fashioning of the purse-string, dilation of the esophagus, or in stapling). Among the factors recognized as potentially preventing leakage, only testing for airtightness was significantly correlated with less postoperative leakage (p0.05). Eight postoperative strictures were recorded at 3 months in 62 (13%) patients in the manual group, whereas seven strictures occurred in 53 (13%) patients in the mechanical group.When mechanical staples rather than manual sutures are chosen, the disadvantages (technical mishaps and higher costs) are not counterbalanced by a gain of time or a decrease in the rate or severity of anastomotic leakage.

Although used widely for supraperitoneal anastomoses, circular stapled anastomoses have never been proved better than hand-sewn anastomoses. In the one prospective controlled trial that studied these anastomoses specifically, the only significant difference found was that there were more clinically obvious leakages with the circular stapled variety, but not in the overall clinical and roentgenologic leakage rates.One hundred fifty-nine consecutive patients (88 men and 71 women, mean age 65.8 +/- 12.1 years) were randomized to undergo hand-sewn (n = 74) or circular stapled (n = 85) supraperitoneal colorectal anastomosis after left colectomy.Patient demographics were similar in both groups. Overall mortality was 1.3% (2 of 159; one in each group). No statistically significant difference (NS) was found in the rate of early complications, including anastomotic leakage (4 of 74 versus 6 of 85) in the hand-sewn and stapled anastomoses, respectively). Mishaps (n = 10) and hemorrhage (n = 5) occurred in the stapled group only. Stapled anastomoses took an average of 8 minutes less to perform (p0.001), but this time gain did not significantly influence the overall duration of operation (identical median times). The median duration of hospitalization was 13 and 14 days, respectively (NS). At 8 months there were 2 of 74 strictures in the hand-sewn group and 4 of 85 strictures in the stapled group (NS).According to these results, there seems to be no advantage of routine or regular use of stapling instruments for supraperitoneal colorectal anastomosis.

Disagreement continues among several studies as to the relative advantages and disadvantages of stapled versus sutured colorectal anastomoses.One hundred and thirteen consecutive patients (48 men and 65 women, mean age: 67 +/- 12 years) were randomized to either hand-sewn (n = 59) or stapled (n = 54) infraperitoneal colorectal anastomosis. Both groups had similar patient demographics except that fewer patients (4 versus 15) had chronic disease (p0.02) and were undergoing side-to-end (11 versus 39) and more patients were undergoing end-to-end (37 versus 20) anastomosis in the stapled group (p0.001).Overall mortality was 6% (7 of 113 patients), with no difference found between the two types of anastomosis. Fewer anastomotic leaks occurred in the stapled group (11 versus 7), with an a posteriori gamma error of 11%, whereas the other early postoperative complications occurred with similar frequency in the two groups. Nine mishaps occurred in the stapled group. Stapled anastomoses took less time (median, 42 versus 30 minutes) to perform (p0.02). At 8 months, two strictures occurred in the hand-sewn group (n = 52) compared with eight strictures in the stapled group (n = 50) (p0.001).It was not possible to prove that lower anastomosis can be achieved with the stapling device. Routine or regular use of stapling instruments for infraperitoneal colorectal anastomosis cannot be advocated because of higher incidence of mishaps and strictures, even though the operation takes less time to perform and anastomotic leakage occurs less often.