Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

NCT ID: NCT03671031

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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isolated roux loop

isolated roux loop reconstruction following pancreaticoduodenectomy as the first group.

isolated roux loop

Intervention Type PROCEDURE

Isolated roux loop reconstruction following pancreaticoduodenectomy

single loop

single loop reconstruction following pancreaticoduodenectomy as the second group.

single loop

Intervention Type PROCEDURE

Conventional single loop reconstruction following pancreaticoduodenectomy

Interventions

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isolated roux loop

Isolated roux loop reconstruction following pancreaticoduodenectomy

Intervention Type PROCEDURE

single loop

Conventional single loop reconstruction following pancreaticoduodenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Egemen Ozdemir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Egemen Ozdemir, MD

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

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Inonu University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. doi: 10.3748/wjg.v11.i16.2456.

Reference Type BACKGROUND
PMID: 15832417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23494109 (View on PubMed)

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. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.

Reference Type BACKGROUND
PMID: 17710506 (View on PubMed)

Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.

Reference Type BACKGROUND
PMID: 17236843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22622664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 941087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7912489 (View on PubMed)

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. doi: 10.1097/00007611-199402000-00010.

Reference Type BACKGROUND
PMID: 8115883 (View on PubMed)

Other Identifiers

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2018/16-22

Identifier Type: -

Identifier Source: org_study_id

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