PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-01-15

AUTHORS

Christopher M. Halloran, Kellie Platt, Abbie Gerard, Fotis Polydoros, Derek A. O’Reilly, Dhanwant Gomez, Andrew Smith, John P. Neoptolemos, Zahir Soonwalla, Mark Taylor, Jane M. Blazeby, Paula Ghaneh

ABSTRACT

BackgroundFailure of the pancreatic remnant anastomosis to heal following pancreato-duodenectomy is a major cause of significant and life-threatening complications, notably a post-operative pancreatic fistula. Recently, non-randomized trials have shown superiority of a most intuitive anastomosis (Blumgart technique), which involves both a duct-to-mucosa and a full-thickness pancreatic “U” stitch, in effect a mattress stitch, over a standard duct-mucosa technique (Cattell-Warren). The aim of this study is to examine if these findings remain within a randomized setting.Methods/DesignThe PANasta trial is a randomized, double-blinded multi-center study, whose primary aim is to assess whether a Blumgart pancreatic anastomosis (trial intervention) is superior to a Cattell-Warren pancreatic anastomosis (control intervention), in terms of pancreatic fistula rates. Patients with suspected malignancy of the pancreatic head, in whom a pancreato-duodenectomy is recommended, would be recruited from several UK specialist regional centers. The hypothesis to be tested is that a Blumgart anastomosis will reduce fistula rate from 20 to 10 %. Subjects will be stratified by research site, pancreatic consistency and diameter of pancreatic duct; giving a sample size of 253 per group. The primary outcome measure is fistula rate at the pancreatico-jejunostomy. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay, cancer-specific quality of life and health economic assessments. Enrolled patients will undergo pancreatic resection and be randomized immediately prior to pancreatic reconstruction. The operation note will only record “anastomosis constructed as per PANasta trial randomization,” thus the other members of the trial team and patient are blinded. An inbuilt internal pilot study will assess the ability to randomize patients, while the construction of an operative manual and review of operative photographs will maintain standardization of techniques.DiscussionThe PANasta trial will be the first multi-center randomized controlled trial (RCT) comparing two types of duct-to-mucosa pancreatic anastomosis with surgical quality assurance.Trial registrationISRCTN52263879. Date of registration 15 January 2015. More... »

PAGES

30

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-015-1144-9

DOI

http://dx.doi.org/10.1186/s13063-015-1144-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1043978699

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26772736


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20 schema:description BackgroundFailure of the pancreatic remnant anastomosis to heal following pancreato-duodenectomy is a major cause of significant and life-threatening complications, notably a post-operative pancreatic fistula. Recently, non-randomized trials have shown superiority of a most intuitive anastomosis (Blumgart technique), which involves both a duct-to-mucosa and a full-thickness pancreatic “U” stitch, in effect a mattress stitch, over a standard duct-mucosa technique (Cattell-Warren). The aim of this study is to examine if these findings remain within a randomized setting.Methods/DesignThe PANasta trial is a randomized, double-blinded multi-center study, whose primary aim is to assess whether a Blumgart pancreatic anastomosis (trial intervention) is superior to a Cattell-Warren pancreatic anastomosis (control intervention), in terms of pancreatic fistula rates. Patients with suspected malignancy of the pancreatic head, in whom a pancreato-duodenectomy is recommended, would be recruited from several UK specialist regional centers. The hypothesis to be tested is that a Blumgart anastomosis will reduce fistula rate from 20 to 10 %. Subjects will be stratified by research site, pancreatic consistency and diameter of pancreatic duct; giving a sample size of 253 per group. The primary outcome measure is fistula rate at the pancreatico-jejunostomy. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay, cancer-specific quality of life and health economic assessments. Enrolled patients will undergo pancreatic resection and be randomized immediately prior to pancreatic reconstruction. The operation note will only record “anastomosis constructed as per PANasta trial randomization,” thus the other members of the trial team and patient are blinded. An inbuilt internal pilot study will assess the ability to randomize patients, while the construction of an operative manual and review of operative photographs will maintain standardization of techniques.DiscussionThe PANasta trial will be the first multi-center randomized controlled trial (RCT) comparing two types of duct-to-mucosa pancreatic anastomosis with surgical quality assurance.Trial registrationISRCTN52263879. Date of registration 15 January 2015.
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27 Blumgart anastomosis
28 Secondary outcome measures
29 Warren
30 ability
31 adjuvant therapy
32 aim
33 anastomosis
34 assessment
35 assurance
36 cancer-specific quality
37 cause
38 center
39 complications
40 consistency
41 construction
42 date
43 diameter
44 duct
45 economic assessment
46 effect
47 entry
48 findings
49 fistula
50 fistula rate
51 group
52 head
53 health economic assessment
54 hospital stay
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56 internal pilot study
57 life
58 life-threatening complications
59 major cause
60 malignancy
61 manual
62 mattress stitches
63 measures
64 members
65 mortality
66 mucosa
67 multi-center study
68 non-randomized trials
69 non-surgical complications
70 note
71 operation notes
72 operative manual
73 operative photographs
74 outcome measures
75 pancreatic anastomosis
76 pancreatic consistency
77 pancreatic duct
78 pancreatic fistula
79 pancreatic fistula rate
80 pancreatic head
81 pancreatic reconstruction
82 pancreatic resection
83 pancreatico-jejunostomy
84 patients
85 photographs
86 pilot study
87 post-operative pancreatic fistula
88 primary aim
89 primary outcome measure
90 protocol
91 quality
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93 randomization
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95 rate
96 reconstruction
97 regional centers
98 research sites
99 resection
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105 standardization
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107 stay
108 stitches
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111 superiority
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114 team
115 technique
116 terms
117 therapy
118 trial randomization
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