Risk Prediction for Development of Pancreatic Fistula Using the ISGPF Classification Scheme

Background: The International Study Group on Pancreatic Fistula (ISGPF) classification scheme has become a useful system for characterizing the clinical impact of pancreatic fistula. We sought to identify predictive factors that predispose patients to fistula, specifically those with clinical relevance (grades B/C), and to describe the clinical and economic significance of risk stratification within this framework. Methods: Overall, 233 consecutive pancreatoduodenectomies were performed between October 2001 and March 2007 in our institution. Pancreatic fistula is defined according to the ISGPF classification scheme. Logistic regression analysis was performed to identify risk factors for pancreatic fistula development. These features were then analyzed to determine whether additive risk severity equates to worsening clinical and economic impact. Results: Fistulas of any extent occurred in 60 patients, but only 31 (14%) were clinically relevant. There are no identifiable risk factors for grade A biochemical fistulas. Multivariate analysis shows that small pancreatic duct size (<3 mm); soft gland texture; ampullary, duodenal, cystic, or islet cell pathology; and increased intraoperative blood loss (> 1,000 ml) are associated with clinically relevant fistulae. An additive effect is further illustrated, in which clinical and economic outcomes progressively worsen as risk profile increases. Each additional risk factor increases the odds of developing a clinically relevant fistula by 52%. Conclusions: For pancreatoduodenectomy, small duct size; soft gland texture; ampullary, duodenal, cystic, or islet cell pathology; and increased intraoperative blood loss are convincing risk factors for the development clinically relevant fistulae as judged by ISGPF classification. As risk profile accrues, patients suffer more complications, encounter longer hospital stays, and incur greater hospital costs. These outcomes can be predicted in the operating room through accurate delineation of high-risk glands. Presented at the American Hepato Pancreato Biliary Association, Annual Meeting, Las Vegas, NV; April 21, 2007, and the Pancreas Club Annual Meeting, Washington, DC, May 20, 2007.     

Postoperative pancreatic fistulas are not equivalent after proximal, distal, and central pancreatectomy

It is uncertain whether postoperative pancreatic fistulas after distal and central pancreatectomies behave similarly to those after pancreaticoduodenectomy. To date, this concept has not been validated either clinically or economically. Overall, 256 consecutive pancreatic resections from October 2001 to February 2006 (184 pancreaticoduodenectomies, 66 distal pancreatectomies, and 6 central pancreatectomies) were evaluated according to the International Study Group of Pancreatic Fistula classification scheme. Pancreatic fistula was defined as any measurable drainage on or after postoperative day 3, with amylase content greater than three times the normal serum value. Outcomes were divided into four grades: (1) no fistula, (2) grade A: biochemical fistula without clinical sequelae, (3) grade B: fistula requiring any therapeutic intervention, or (4) grade C: fistula with severe clinical sequelae. Grades B and C are considered clinically relevant fistulas based on worsening morbidity, increased length of stay, frequent hospital readmission, and increased costs/resource utilization. Clinical and economic outcomes were compared—grade for grade—across the three resection types. Fistulas of any extent (Grades A-C) occurred in one third of all patients; two thirds had no fistula. Overall, there were 16 readmissions (6%), six re-operations (2%), and no deaths attributable to pancreatic fistula. Outcomes between no fistula and grade A patients were identical across resection types, though grade A fistula was more common in distal pancreatectomy. For each resection type, length of stay and costs progressively increased with grades B and C. However, the negative impact of these clinically relevant fistulas varied between resection types. Rates for intensive care unit admission and rehabilitation placement were higher among pancreaticoduodenectomy patients. Total parenteral nutrition and antibiotic use were similar, but percutaneous drainage was used more often for distal pancreatectomy. Grade B fistula was more severe after distal pancreatectomy, as indicated by increased length of stay, readmissions, and total cost. Although reoperation rates for grade C fistulas were equivalent, intervals to reoperation were substantially longer after distal and central pancreatectomies. When classified according to International Study Group of Pancreatic Fistula criteria, clinically relevant pancreatic fistulas behaved differently depending on type of pancreatectomy. This translates into variable severity that guides management decisions, which ultimately dictate clinical outcomes and economic impact. Presented at the Forty-Seventh Annual Meeting of The Society for Surgery of the Alimentary Tract, Los Angeles, California, May 20–24, 2006 (oral presentation). Supported by a Clinical Research Fellowship Award funded through the Doris Duke Charitable Foundation to W.P., the Harvard PASTEUR Program, and Office of Enrichment Programs.     

How Do We Predict the Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy?—An Analysis in 244 Consecutive Patients

Background  

The most important problem in pancreatic fistula is whether one can distinguish clinical pancreatic fistula, grade B + C fistula by the International Study Group on Pancreatic Fistula (ISGPF), from transient pancreatic fistula (grade A), in the early period after pancreaticoduodenectomy (PD). It remains unclear what predictive risk factors can precisely predict which clinical relevant or transient pancreatic fistula when diagnosed pancreatic fistula on POD3 by ISGPF criteria.     

Clinical Validation of the ISGPF Classification and the Risk Factors of Pancreatic Fistula Formation Following Duct-to-Mucosa Pancreaticojejunostomy by One Surgeon at a Single Center

Background  

Postoperative pancreatic fistula remains a troublesome complication after pancreatoduodenectomy (PD), and many authors have suggested factors that affect pancreatic leakage after PD. The International Study Group on Pancreatic Fistula (ISGPF) published a classification, but the new criteria adopted have not been substantially validated. The aims of this study were to validate the ISGPF classification and to analyze the risk factors of pancreatic leakage after duct-to-mucosa pancreatojejunostomy by a single surgeon.     

Impact of Postoperative Pancreatic Fistula on Surgical Outcome—The Need for a Classification-driven Risk Management

Background

The International Study Group of Pancreatic Fistula (ISGPF) classification allows comparison of incidence and severity of postoperative pancreatic fistula (POPF). Its post hoc character, however, does not provide a guideline for the treatment of POPF in individual patient. We therefore studied the association of POPF type A-C on secondary surgical morbidity and mortality in patients undergoing pancreatic resection.

Patients and methods

Between 3/2001-12/2007, 483 patients underwent pancreatic resections. POPF were classified according to the ISGPF classification. All patient data were entered in a clinical data management system prospectively.

Results

Patients who developed POPF had significantly more vascular but not other surgical complications than patients without POPF. Patients with POPF A had no vascular or surgical complications. Twenty one of the 29 patients with POPF C had surgical complications (17 vascular complications). Mortality attributed to surgical complications after POPF C was 5/29. A soft pancreatic consistency (OR 8.5; p?<?0.008) and a high drain lipase activity on postoperative day 3 (OR 4.4; p?=?0,065) were predictors for the development of POPF C.

Discussion

POPF C is associated with vascular complications like erosion bleeding and other surgical complications like delayed gastric emptying or pleural effusions. A soft pancreatic consistency and a high drain lipase activity on postoperative day?3 are early predictors for the development of POPF C.     

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??Updates and interpretations of PODF definition and grading system (2016 edition) by ISGPS SHI Si, XIANG Jin-feng, XU Jin, et al. Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai 200032, China
Corresponding author: YU Xian-jun, E-mail: yuxianjun@
fudanpci.org
Abstract The definition and grading system of postoperative pancreatic fistula (PODF) developed by the International Study Group of Pancreatic Fistula (ISGPF) in 2005 has been widely accepted. However, the use of the process found that the version of the definition and classification system, there are still some problems and shortcomings. Based on this, the International Pancreatic Surgery Research Group (ISGPS) updated the relevant content, published 2016 version ,which is more concise and has clinical value than 2005 version. In 2005 version , PODF was emphasized as a complication that closely associated with the clinical management. A former grade A has been renamed as Biochemical Leak (BL) which is no longer considered as a fistula in 2016 version. Besides, grades B and C are defined more strictly. In particular, grade B requires a change in the postoperative management. Drains either left in place >3 weeks or repositioned through endoscopic or percutaneous is definitely considered as grade B. On the other hand, grade C refers to POPF that needs reoperation or leads to single/multiple organ failure and/or mortality.     

贯穿缝合式胰肠吻合术83例报告

目的：探讨贯穿缝合式胰肠吻合术的临床应用价值。方法：回顾性分析2006年5月—2014年7月83例胰十二指肠切除术患者的临床资料。患者术中采用贯穿缝合式胰肠吻合术行胰肠吻合,即胰腺切面（而非切缘）与空肠壁、胰管与肠黏膜之间吻合。结果：83例中胰头癌32例,壶腹部周围癌42例,其他疾病9例;根治性胰十二指肠切除81例,非根治性切除2例。手术时间220~350 min,平均290 min;胰肠吻合时间6~22 min,平均8 min。按ISGPF诊断标准,术后具有临床意义的胰瘘8例（9.6%）,均为B级单纯性胰瘘;胆汁漏2例;胃排空障碍6例;无吻合口出血、无再手术和手术死亡病例。结论：采用贯穿缝合式胰肠吻合技术可以有效地防止术后胰肠吻合失败及吻合口出血。

     

Selective administration of prophylactic octreotide during pancreaticoduodenectomy: a clinical and cost-benefit analysis in low- and high-risk glands

BACKGROUND: The efficacy of prophylactic octreotide after pancreaticoduodenectomy has been rigorously scrutinized, yet few studies have specifically illustrated its impact in patients at high risk for pancreatic fistula. Applying a previously validated clinical classification scheme (International Study Group on Pancreatic Fistula) for postoperative pancreatic fistula severity, we examined whether prophylactic octreotide could effectuate a clinical or fiscal benefit, or both, after pancreatic resection. STUDY DESIGN: There were 227 consecutive patients who underwent pancreaticoduodenectomy from October 2001 to January 2007. At the surgeon's discretion, prophylactic octreotide was administered intraoperatively and continued postoperatively. Clinically relevant fistulas, requiring therapeutic interventions or resulting in severe clinical sequelae, were identified, as were other complications. Through multivariate analysis, risk factors for fistula were defined as soft gland texture; small duct size; ampullary, duodenal, cystic, or islet cell pathology; and increased blood loss. Beyond a traditional review of clinical outcomes, a novel economic cost-benefit analysis of octreotide prophylaxis was performed, with concentration of impact on high-risk glands (one or more risk factors). RESULTS: Overall, 55% of patients had at least one risk factor. Clinically relevant fistulas were present in 14.9% of all patients. High-risk glands resulted in significantly worse clinical and economic outcomes compared with low-risk glands (no risk factors present). Prophylactic octreotide in low-risk glands was neither clinically effective nor cost efficient after pancreaticoduodenectomy, contributing to $781 in overspending per patient--approximately equivalent to a 7-day postoperative course of octreotide. But in patients with high-risk glands, octreotide prophylaxis was associated with a decreased incidence (20% versus 35%) and morbidity of clinically relevant fistulas. These improved clinical outcomes were associated with reduced resource use, translating to considerable cost savings ($11,849) per high-risk patient. CONCLUSIONS: Octreotide prophylaxis is an effective approach to mitigate the negative impact of pancreatic fistulas, but to obtain maximal clinical value and cost benefit, octreotide should be administered exclusively to patients with high-risk glands.     

Life-threatening postoperative pancreatic fistula (grade C) after pancreaticoduodenectomy: incidence, prognosis, and risk factors

Background

Pancreatic fistula (PF) is one of the most common postoperative complications of pancreatoduodenectomy (PD). A recent International Study Group on Pancreatic Fistula (ISGPF) definition grades the severity of PF according to the clinical impact on the patient's hospital course. Although PF is generally treated conservatively (grade A), some cases may require interventional procedures (grade B) or may be life-threatening and necessitate emergency reoperation (grade C). The aim of the present study was to evaluate the incidence of postoperative grade C PF after PD and to assess the prognosis and risk factors for this life-threatening condition.

Study design

Between January 2000 and December 2006, 680 consecutive patients underwent PD in 5 digestive surgery departments in the northwest region of France (Lille, Amiens, Rouen, and Caen). PF was defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the serum amylase activity (ISGPF guidelines). To identify possible risk factors for grade C PF, we reviewed the records of 111 (16.3%) patients with postoperative PF and compared grade C cases with grade A+B cases.

Results

The median age was 59 years (range 22-87). The male-to-female ratio was 1.6:1. Fifty-six (50.4%) PDs were performed via pancreaticogastrostomy and 55 via pancreaticojejunostomy. Overall mortality was 2% (n = 14). Grade C PF was observed in 36 (32%) patients, of whom 17 (47%) had sepsis due to an abdominal collection, 16 (44%) had postoperative bleeding, 10 (27.7%) had bleeding associated with abdominal collection, and 3 (9%) had multi-organ failure due to other causes. Of these 36 patients, 35 (97%) underwent reoperation. The mortality rate in grade C PF patients was 38.8%. The major causes of death were sepsis (n = 6) and recurrent bleeding after reoperation (n = 5). Grade C PF increased the duration of postoperative hospitalization (46 vs 29 days, P < .001). Univariate analysis showed that peroperative soft pancreatic parenchyma, peroperative blood transfusion, and postoperative bleeding were significant risk factors for grade C PF, with P values of .011, .003, and .001, respectively. No risk factors for grade C PF were identified in a multivariate analysis. The sensibility, specificity, positive predictive value, and negative predictive value of the presence of the 3 risk factors for grade C PF were 13.89%, 100%, 100%, and 70.75%, respectively.

Conclusion

Sixteen percent of patients had PF after PD. Among them, 30% had grade C PF, with a mortality rate of about 40%. Achievement of a 100% predictive positive value for grade C PF after PD in individuals with 3 discriminant risk factors (peroperative soft pancreatic parenchyma, peroperative transfusion, and postoperative bleeding) is a first step towards the identification of high-risk patients who should be managed differently from other patients with PF during or after PD.     

胰十二指肠切除术后胰瘘合并出血二次手术2例并国内文献复习

目的 关于胰十二指肠切除术后胰瘘合并出血的二次手术方式缺乏相应的指南及专家共识,本文旨在复习胰十二指肠切除术后胰瘘合并出血的二次手术方式并探讨胰十二指肠切除术后胰瘘合并出血治疗方案。方法 回顾分析2例胰十二指肠切除术后C级胰瘘合并出血的诊疗及手术过程,对胰十二指肠切除术后胰瘘合并出血的二次手术方式进行文献复习。结果 2例胰十二指肠切除术后C级胰瘘合并出血的患者,均在保守治疗无效的情况下进行了二次手术。患者1在探查胰肠吻合口时,发现门静脉出血,确切止血后重新行原位的胰肠吻合术,最终痊愈出院;患者2由于胰瘘导致了迟发性的出血及腹腔感染,在二次手术时并未发现明确的责任血管,手术中对出血风险较高的血管进行了结扎,并对胰肠吻合口进行了加针修补,最终患者因全身多器官功能衰竭死亡。结论 PD术后胰瘘合并出血的治疗需要介入科、重症医学科、普外科的多学科参与,外科手术仍然是PD术后胰瘘合并出血的关键一环。