Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798560
• Other study ID #: 8515/31-05-2019
• Status: Recruiting
• Start date: October 10, 2018
• Est. completion date: May 2022

Study information

• Verified date: March 2021
• Source: University of Athens
• Contact: Dimitrios Vouros, MD, MSc
• Phone: +30 2132088142
• Email: jimsamiotis[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.

Description:

This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens, Greece. Patients with imaging and/or histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery. Patients information and medical history will be recorded, giving emphasis on clinical presentation, signs and symptoms related to the patients disease. Laboratory tests will afterwards take place, including biochemical parameters such as total bilirubin levels, serum albumin, CA 19-9, CEA, HbA1c and ferritine levels prior to operation. During operation, as soon as the specimen has been removed, the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions (horizontal/vertical). The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm. Pancreatic texture will also be assesed. Other intraoperative datas will be recorded such as the anastomosis technique, duration of surgery, amount of fluid administration, transfusion with fresh frosen plasma or blood units.Postoperatively, amylase from the drains, white blood cell count, platelet count and serum crp levels will be recorded on the 1st, 3rd and 5th postoperative day in all patients. The definition used for postoperative pancreatic fistula (POPF) is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly. There will be two arms of patients. The first arm will include patients with either no POPF or Biochemical Leak (BL) and the second arm patients with Grade B or C POPF.

Any complication in the early postoperative period ,defined as the first 30 days after Whipple operation, will be recorded and categorised according to Clavien Dindo classification, including reoperation, readmissions or prolongation of hospital stay. After discharge, follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one, three, six and twelve months after surgery. Reccurence and survival rates will accordingly be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age more than or equal to 18 years

2. periampullary pathologies (benign or malignant) with indication for panceaticoduodenectomy

3. Pancreaticojejunal anastomosis performed

4. Curative resection

5. Signed informed consent form -

Exclusion Criteria:

1. Age less than 18 years old

2. One stage total pancreatectomy

3. External wirsungostomy without pancreaticojejunal anastomosis

4. Subtotal pancreatectomy without pancreaticojejunal anastomosis

5. Left pancreatectomies

6. Intraoperatively findings of unresectable tumors

7. Pregnancy

8. Concurrent participation in other study(ies)

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreaticoduodenectomy
• POPF
• Whipple Operation

Intervention

Procedure:
• Pancreaticoduodenectomy
Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF

Locations

Country	Name	City	State
Greece	1st Propaedeutic Department of Surgery, Hippokrateion General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Dimitrios Vouros

Country where clinical trial is conducted

Greece, 

References & Publications (6)

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. Review. — View Citation

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28. Review. — View Citation

Cullen JJ, Sarr MG, Ilstrup DM. Pancreatic anastomotic leak after pancreaticoduodenectomy: incidence, significance, and management. Am J Surg. 1994 Oct;168(4):295-8. — View Citation

Denbo JW, Orr WS, Zarzaur BL, Behrman SW. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford). 2012 Sep;14(9):589-93. doi: 10.1111/j.1477-2574.2012.00486.x. Epub 2012 May 28. Review. — View Citation

Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018. Review. — View Citation

Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Postoperative pancreatic fistula after pancreaticoduodenectomy	Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition	30 days
Secondary	Mortality	Mortality rates expressed in % of the patients	30 days
Secondary	Morbidity	Morbidity rates expressed in % of the patients	30 days
Secondary	Postoperative complications	Complications classified according to Clavien-Dindo Classification taking measures from I up to V	30 days
Secondary	Duration of Hospital stay	Duration of Hospital stay in days	60 days
Secondary	Readmission	Readmission rates expressed in % of the patients	30 days
Secondary	Reoperation	Reoperation rates expressed in % of the patients	30 days
Secondary	Overall survival	Estimation of days from operation until death expressed in days	2 years