Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial

被引：35

作者：

van Grinsven, Janneke ^{[1
,2
]}

van Dijk, Sven M. ^{[1
,2
,3
]}

Dijkgraaf, Marcel G. ^{[3
]}

Boermeester, Marja A. ^{[1
]}

Bollen, Thomas L. ^{[4
]}

Bruno, Marco J. ^{[5
]}

van Brunschot, Sandra ^{[6
,7
]}

Dejong, Cornelis H. ^{[8
,9
]}

van Eijck, Casper H. ^{[10
]}

van Lienden, Krijn P. ^{[11
]}

Boerma, Djamila ^{[2
]}

van Duijvendijk, Peter ^{[12
]}

Hadithi, Muhammed ^{[13
]}

Haveman, Jan Willem ^{[14
]}

van der Hulst, Rene W. ^{[15
]}

Jansen, Jeroen M. ^{[16
]}

Lips, Daan J. ^{[17
]}

Manusama, Eric R. ^{[18
]}

Molenaar, I. Quintus ^{[7
]}

van der Peet, Donald L. ^{[19
]}

Poen, Alexander C. ^{[20
]}

Quispel, Rutger ^{[21
]}

Schaapherder, Alexander F. ^{[22
]}

Schoon, Erik J. ^{[23
]}

Schwartz, Matthijs P. ^{[24
]}

Seerden, Tom C. ^{[25
]}

Spanier, B. W. Marcel ^{[26
]}

Straathof, Jan Willem ^{[27
]}

Venneman, Niels G. ^{[28
]}

van de Vrie, Wim ^{[29
]}

Witteman, Ben J. ^{[30
]}

van Goor, Harry ^{[31
]}

Fockens, Paul ^{[6
]}

van Santvoort, Hjalmar C. ^{[2
,7
]}

Besselink, Marc G. ^{[1
]}

机构：

[1] Univ Amsterdam, Amsterdam UMC, Dept Surg, G4-196,POB 26000, NL-1105 AZ Amsterdam, Netherlands

[2] St Antonius Hosp Nieuwegein, Dept Surg, Nieuwegein, Netherlands

[3] Univ Amsterdam, Amsterdam UMC, Clin Res Unit, Amsterdam, Netherlands

[4] St Antonius Hosp Nieuwegein, Dept Radiol, Nieuwegein, Netherlands

[5] Erasmus MC, Univ Med Ctr Rotterdam, Dept Gastroenterol & Hepatol, Rottedam, Netherlands

[6] Univ Amsterdam, Amsterdam UMC, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands

[7] Univ Med Ctr Utrecht, Dept Surg, Canc Ctr, Utrecht, Netherlands

[8] Maastricht Univ, Med Ctr, Dept Surg, Maastricht, Netherlands

[9] NUTRIM Sch Nutr & Translat Res Metab, Maastricht, Netherlands

[10] Erasmus MC, Univ Med Ctr Rotterdam, Dept Surg, Rotterdam, Netherlands

[11] Univ Amsterdam, Amsterdam UMC, Dept Radiol, Amsterdam, Netherlands

[12] Gelre Hosp Apeldoorn, Dept Surg, Apeldoorn, Netherlands

[13] Maasstad Hosp Rotterdam, Dept Gastroenterol & Hepatol, Rotterdam, Netherlands

[14] Univ Groningen, Univ Med Ctr Groningen, Dept Surg, Groningen, Netherlands

[15] Spaarne Gasthuis Haarlem, Dept Gastroenterol & Hepatol, Haarlem, Netherlands

[16] OLVG Amsterdam, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands

[17] Jeroen Bosch Hosp, Dept Surg, Shertogenbosch, Netherlands

[18] Med Ctr Leeuwarden, Dept Surg, Leeuwarden, Netherlands

[19] Vrije Univ Amsterdam, Amsterdam UMC, Dept Surg, Amsterdam, Netherlands

[20] Isala Clin Zwolle, Dept Gastroenterol & Hepatol, Zwolle, Netherlands

[21] Reinier Graaf Gasthuis Delft, Dept Gastroenterol & Hepatol, Delft, Netherlands

[22] Leids Univ, Med Ctr Leiden, Dept Surg, Leiden, Netherlands

[23] Catharina Hosp, Dept Gastroenterol & Hepatol, Eindhoven, Netherlands

[24] Meander Med Ctr Amersfoort, Dept Gastroenterol & Hepatol, Amersfoort, Netherlands

[25] Amphia Hosp Breda, Dept Gastroenterol & Hepatol, Breda, Netherlands

[26] Rijnstate Hosp Arnhem, Dept Gastroenterol & Hepatol, Arnhem, Netherlands

[27] Maxima Med Ctr Veldhoven, Dept Gastroenterol & Hepatol, Veldhoven, Netherlands

[28] Medisch Spectrum Twente Enschede, Dept Gastroenterol & Hepatol, Enschede, Netherlands

[29] Albert Schweitzer Hosp Dordrecht, Dept Gastroenterol & Hepatol, Dordrecht, Netherlands

[30] Hosp Gelderse Vallei Ede, Dept Gastroenterol & Hepatol, Ede, Netherlands

[31] Radboud Univ Nijmegen, Med Ctr Nijmegen, Dept Surg, Nijmegen, Netherlands

来源：

TRIALS | 2019年 / 20卷 / 1期

关键词：

Necrotizing pancreatitis; Infection; Step-up approach; Timing; Drainage; Complication; Randomized controlled trial; STEP-UP APPROACH; PERCUTANEOUS CATHETER DRAINAGE; CLOSED PACKING; NECROSECTOMY; CLASSIFICATION; INTERVENTION; DEBRIDEMENT; EXPERIENCE; MANAGEMENT; STERILE;

D O I：

10.1186/s13063-019-3315-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundInfected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15-20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention.MethodsPOINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6months after randomization.DiscussionThe POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.Trial registrationISRCTN, 33682933. Registered on 6 August 2015. Retrospectively registered.

引用

页数：10

共 50 条

[1] Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial
Janneke van Grinsven
Sven M. van Dijk
Marcel G. Dijkgraaf
Marja A. Boermeester
Thomas L. Bollen
Marco J. Bruno
Sandra van Brunschot
Cornelis H. Dejong
Casper H. van Eijck
Krijn P. van Lienden
Djamila Boerma
Peter van Duijvendijk
Muhammed Hadithi
Jan Willem Haveman
René W. van der Hulst
Jeroen M. Jansen
Daan J. Lips
Eric R. Manusama
I. Quintus Molenaar
Donald L. van der Peet
Alexander C. Poen
Rutger Quispel
Alexander F. Schaapherder
Erik J. Schoon
Matthijs P. Schwartz
Tom C. Seerden
B. W. Marcel Spanier
Jan Willem Straathof
Niels G. Venneman
Wim van de Vrie
Ben J. Witteman
Harry van Goor
Paul Fockens
Hjalmar C. van Santvoort
Marc G. Besselink
[J]. Trials, 20
[2] Postponed or Immediate Drainage of Infected Necrotizing Pancreatitis (POINTER): A Multicenter Randomized Trial
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