Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671031
• Other study ID #: 2018/16-22
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8).

In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who underwent pancreaticoduodenectomy.

Exclusion Criteria:

• patients with missing data

• patients who underwent total pancreatectomy

• patients who had pancreaticogastrostomy as the reconstruction method

• patients who had emergency pancreaticoduodenectomy

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• isolated roux loop
Isolated roux loop reconstruction following pancreaticoduodenectomy
• single loop
Conventional single loop reconstruction following pancreaticoduodenectomy

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Albertson DA. Pancreaticoduodenectomy with reconstruction by Roux-en-Y pancreaticojejunostomy: no operative mortality in a series of 25 cases. South Med J. 1994 Feb;87(2):197-201. — View Citation

El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5. — View Citation

Kingsnorth AN. Safety and function of isolated Roux loop pancreaticojejunostomy after Whipple's pancreaticoduodenectomy. Ann R Coll Surg Engl. 1994 May;76(3):175-9. — View Citation

Machado MC, da Cunha JE, Bacchella T, Bove P. A modified technique for the reconstruction of the alimentary tract after pancreatoduodenectomy. Surg Gynecol Obstet. 1976 Aug;143(2):271-2. — View Citation

Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. Epub 2007 Aug 21. — View Citation

Wente MN, Shrikhande SV, Müller MW, Diener MK, Seiler CM, Friess H, Büchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. Review. — View Citation

Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24. Review. — View Citation

Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of postoperative pancreatic fistula	Assessed according to International Study Group on Pancreatic Fistula definition	1 week
Secondary	Rate of postoperative pancreatic fistula	Number of participants with postoperative pancreatic fistula	1 week
Secondary	Operation time	in minutes	1 week
Secondary	Duration of hospital stay	in days	1 week
Secondary	Duration of intensive care unit stay	in days	1 week
Secondary	30-day mortality	Number of participants died in 30 days after operation	1 week