Triveneta – Udine, Aprile 2006 Il problema della definizione delle complicanze in chirurgia pancreatica

Prof. Claudio Bassi MD

Surgical and Gastroenterological Department
UNIVERSITY of VERONA

claudio.bassi@univr.it

“spiffero”!) in pancreatic surgery is the underlining phenomena of

Pancreatic fistula collections

 Peripancreatic

 Peripancreatic  DGE

abscess

 Bleeding

Pancreatic Fistula… DO WE SPEAK THE SAME LENGUAGE?

Salvia R. Dig Surg 21:54-59. Mascetta G... Gumbs A. . and Pederzoli P. The importance of definitions .2004.Bassi C. Butturini G... Falconi M. Pancreatic fistula rate after pancreatic resection. Molinari E...

score was assigned to the reproducible definitions.Post-operative Pancreatic Fistula A Medline search of the last 10 years. A .

Post-operative Pancreatic Fistula  The Medline search of the last 10 years identified 26 different definitions. definitions were found suitable for the applied score.  14/26 .

F.duration .Score System Score Output (cc/day) Timing * 1 2 >100 >50 >11 8-10 3 4 >25 >10 4-7 >4 * The sum between starting day and P.

(Score 7) D2: Output more than 10cc/day of amylase rich fluid since 8th p.o day or for more than 4 days. (Score 6) D3: Output between 25 cc/day and 100cc/day of amylase rich fluid since 4th p. D1: Output more than 10cc/day of amylase rich fluid since 4th p.Four final definitions summarizing the current pancreatic fistula concept according to the literature.o day or for more than 4 days.o day or for more than 11 days.o day or for more than 8 days. (Score 3) . (Score 5 and 4) D4: Output more than 50 cc/day of amylase rich fluid since 11th p.

Post-operative Pancreatic Fistula  The 4 definitions were applied to 242 pancreatic head resections with P-J carried out from 1997 to 2000 in our Institution.  The .05). Chi-Square test Yates correct test was than applied (p<0.

5%) D3: Output between 25 cc/day and 100cc/day of amylase 40 rich fluid since 4th p.9%) . (28.o day or for more than 4 days.F.5%) D4: Output more than 50 cc/day of amylase rich fluid 24 since 11the p.o day or for more than 5 days. . (18.Incidence of pancreatic fistula in 242 patients using four different definitions Definition P. (16. D1: Output more than 10cc/day of amylase rich fluid 69 since 5th p. (9.5%) D2: Output more than 10cc/day of amylase rich fluid 44 since 8th p.o day or for more than 11 days.o day or for more than 8 days.

“GENTLEMAN AGREEMENT” AMONG PANCREATIC SURGEONS! upon an objective and internationally accepted definition to allow comparison of different surgical experiences! .

Helmut Friess (Heidelberg. Greece). Tibor Tihani (Budapest. Netherland). Germany). Yugoslavia). Sweden). Japan). Charles Yeo (Baltimore. Mike Mac Mahon (Leeds. Josè Eduardo Cunha (San Paulo. John Neoptolemos MD (Liverpool. UK). Krzysztof Bielecki (Warsaw. Christos Dervenis (Athens. Attila Olah (Gyor. USA). Clem Imrie (Glasgow. USA). Rob Petbury (Adelaide. Michael Sarr (Rochester. Colin Johnson (Southampton. Brasil). Valerio Di Carlo (Milan. UK). Robin Williamson (London.POST – OPERATIVE PANCREATIC FISTULA: CONSENSUS DEFINITION Members of the International Study Group on Pancreatic Fistula Definition: Claudio Bassi (Verona. Roland Andersson (Lund. Spain). Keith Lillemoe (Indianapolis. Carlos Fernandez de Castillo (Boston. Italy). Japan). Masayuki Imamura (Kyoto. Dirk Gouma (Amsterdam. USA). UK). Giovanni Butturini . Milicevic Miroslav (Belgrade. Jakob Izibicki (Hamburg. Germany). UK). Australia). Hungary). Germany). Poland). William Traverso (Seattle. Laureano Fernanadez Cruz (Barcelona. France). Tadahiro Takada (Tokio. Marcus Buchler (Heidelberg. Sweden). Gregor Tsiotos (Athens. Greece). Efthimios Chatzitheoklitos (Thessaloniki. USA). Hungary). Greece). USA). Abe Fingerhut (Poissy. Andren Ake Sandberg (Gothemburg. UK). Italy).

and/or trauma.rich fluid.g.138:8  A general definition of pancreatic fistula is an abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas – derived. e. enzyme . . a surgical drain. However POPF represents a failure of healing/sealing of a pancreatic-enteric anastomosis or it may represent a parenchymal leak not directly related to an anastomosis such as one originating from the raw pancreatic surface. enucleation.POST – OPERATIVE PANCREATIC FISTULA: CONSENSUS DEFINITION Surgery 2005.g. e. left or central pancreatectomy. In this case there is a leak from the pancreatic ductal system into and around the pancreas and not necessarily to another epithelialized surface.

to greenish bilious fluid. delayed gastric emptying. However imaging may be useful by identifying erosion or migration of the drain into an enteric viscus and thus need for drain withdrawal to allow healing of the site of erosion. to milky water. and fever > 38oC. to clear “spring water” that looks . Serum WBC > 10. Radiologic documentation is neither mandatory nor necessarily recommended for diagnosis. Associated clinical findings may include abdominal pain and distention with impaired bowel function.like pancreatic juice.000 cells/mm3 and increased C – reactive protein may also be present. Drain fluid could have a “sinister appearance” that may vary from dark brown. percutaneous drain) of any measurable volume of drain fluid with amylase content greater than three times the upper normal serum value. . A broad definition begins with the following criteria: output via an operatively-placed drain (or a subsequently placed.FISTULA: CONSENSUS DEFINITION   Suspicion and diagnosis   The diagnosis of POPF may be suspected based on the many clinical or biochemical findings.

“sinister appearance? … no!” take it out as soon as possible!! .

“sinister appearance? …yes!” look to amylase content! .

“sinister appearance? …yes!” look to amylase and bacteria content! .

and fever > 38oC. Serum WBC > 10. Radiologic documentation is neither mandatory nor necessarily recommended for diagnosis. A broad definition begins with the following criteria: output via an operatively-placed drain (or a subsequently placed. to greenish bilious fluid. . However imaging may be useful by identifying erosion or migration of the drain into an enteric viscus and thus need for drain withdrawal to allow healing of the site of erosion. Associated clinical findings may include abdominal pain and distention with impaired bowel function. Drain fluid could have a “sinister appearance” that may vary from dark brown. percutaneous drain) of any measurable volume of drain fluid with amylase content greater than three times the upper normal serum value. to milky water. delayed gastric emptying.000 cells/mm3 and increased C – reactive protein may also be present. to clear “spring water” that looks .like pancreatic juice.FISTULA: CONSENSUS DEFINITION   Suspicion and diagnosis   The diagnosis of POPF may be suspected based on the many clinical or biochemical findings.

Pancreatic fistula .

.

Role of imaging useful by identifying erosion or migration of the drain .

2005.138:8 GRADE Clincal Conditions A Well B Often well C Ill appearing or bad Yes Positive Yes Yes Specific treatment No Yes/No US/CT Drain after 3 weeks Reoperatio n Death Signs of Infections Negative No No Neg//Pos Usually yes No No No No Yes Possibly yes Yes .

Grade A Fistulas 10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death Modified by Pratt et al. from Bassi C et al. . 138: 813. Surgery 2005.

Surgery 2005. from Bassi C et al. 138: 8- .Grade B Fistulas 10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death Modified by Pratt et al.

Grade C Fistulas 10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death Modified by Pratt et al. from Bassi C et al. Surgery 2005. 138: 813. .

.International Study Group on Pancreatic Fistula Definition CONSENSUS DEFINITION Conclusion 1 Only after clinical recovery is complete it is possible to ultimately distinguish and to grade the POPF as Grades A. B and C with respect to the clinical impact.

. new operations.International Study Group on Pancreatic Fistula Definition CONSENSUS DEFINITION Conclusion 2  The present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when addressing new techniques. or new pharmacologic agents that may impact surgical treatment of pancreatic disorders.

Clinical and Economic Validation of the International Study Group on Pancreatic Fistula Classification Scheme Wande Pratt Shishir K. Jr. Vollmer. Maithel Tsafrir Vanounou Zhen Huang Mark P. Callery Charles M. Department of Surgery Beth Israel Deaconess Medical Center Harvard Medical School Doris Duke Charitable Foundation .

Clinical Validation on 176 Whipple Clinically-Relevant Parameters  Hospital stay (LOS and readmission)  Postoperative complications  Costs .

001 Days 20 (median) 35 10 13 8 8 Grade A Grade B Grade C No Fistula 0 ISGPF Grade .Hospital Stay 40 30 p < .

Complications 100% p = .05 Rate 40% 20% 0% No Fistula 37% 12% Grade A Grade B Grade C ISGPF Grade .20 80% 60% 100% 76% p < .

000 $0 No Fistula Grade A Grade B Grade C p < .150 $120.000 (median) $40.000 $100.001 851.52$ 558.000 $20.000 Costs $60.075 ISGPF Grade .81$ $18.000 $80.Total Hospital Costs $113.

Summary ISGPF Classification Scheme  Grade A Fistulas are clinically insignificant  Only Grade B and C fistulas are clinically significant Clinical and Economic Validation  Increasing fistula severity impacts outcomes A New Sub-Classification .ISGPF Scheme  Amylase-Rich vs. Amylase-Deficient Fistulas .

Still “open” problem … Does the drain fluid amylase contain reflect pancreatic leakege? WE NEED INTERNATIONAL SHARING OF DATA … PRELIMINARY DATA FROM ONE SINGLE CENTRE .

137 Evaluated Resections: No POPF VS POPF .

PD: No POPF VS POPF .

Left Pancreatctomy: No POPF VS POPF .

o. ams < 4400 ams > 4400 ams >4400 5 gg.po qualsialsi valore >200 < 200 pz fistola % 86 2 2. correlate A B C Totale complessivo 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 128 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 101 12 1 11 4 3261 3300 3424 3470 3915 4141 4373 4470 5000 5131 5162 5200 6095 6336 7000 7197 7400 8000 8420 8656 8905 9370 10000 10250 10257 10507 10800 11989 13200 14478 14500 15264 16328 17610 18000 18141 19831 20000 27168 28000 40000 42000 47947 54969 58000 100000 Totale complessivo 1 gg p.3256 27 27 100 15 0 0 .o.Conteggio di fistola ams 1sx 2741 2800 3200 ams 5 sx 300 20 100 120 640 50 120 32 83 20 40 20 200 50 490 85 200 665 40 299 150 25 118 2958 0 170 618 1673 530 3140 35 1413 141 550 150 421 430 318 416 131 99 1000 2307 60 1370 70 31000 919 1900 66 2234 6390 50000 fistola2 NO 1 1 1 1 AMS in I° e V°gg p.

o.3256 27 27 100 15 0 0 . day.Preliminary Conclusions High risk with > than 4000 u/ml in the first p.o. • •>200 u/ml in V p.po qualsialsi valore >200 < 200 pz fistola % 86 2 2. day.o. ams < 4400 ams > 4400 ams >4400 5 gg. 1 gg p.

HPB European Chapter. Verona June 2007 .