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; Rene 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; Dutch Pancreatitis Study Grp

doi:10.1186/s13063-019-3315-6

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, Rene W. van der Hulst, Jeroen M. Jansen, Daan J. Lips, Eric R. Manusama, I. Quintus Molenaar, Donald L. van der PeetAlexander 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^*, Dutch Pancreatitis Study Grp

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

23 Citations (Web of Science)

Abstract

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.

Original language	English
Article number	239
Number of pages	10
Journal	Trials
Volume	20
DOIs	https://doi.org/10.1186/s13063-019-3315-6
Publication status	Published - 25 Apr 2019

Keywords

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

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van Grinsven, J., van Dijk, S. M., Dijkgraaf, M. G., Boermeester, M. A., Bollen, T. L., Bruno, M. J., van Brunschot, S., Dejong, C. H., van Eijck, C. H., van Lienden, K. P., Boerma, D., van Duijvendijk, P., Hadithi, M., Haveman, J. W., van der Hulst, R. W., Jansen, J. M., Lips, D. J., Manusama, E. R., Molenaar, I. Q., ... Dutch Pancreatitis Study Grp (2019). Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial. Trials, 20, [239]. https://doi.org/10.1186/s13063-019-3315-6

@article{8979560298bf41d69299f81a6a39c6df,

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

abstract = "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.",

keywords = "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",

author = "{van Grinsven}, Janneke and {van Dijk}, {Sven M.} and Dijkgraaf, {Marcel G.} and Boermeester, {Marja A.} and Bollen, {Thomas L.} and Bruno, {Marco J.} and {van Brunschot}, Sandra and Dejong, {Cornelis H.} and {van Eijck}, {Casper H.} and {van Lienden}, {Krijn P.} and Djamila Boerma and {van Duijvendijk}, Peter and Muhammed Hadithi and Haveman, {Jan Willem} and {van der Hulst}, {Rene W.} and Jansen, {Jeroen M.} and Lips, {Daan J.} and Manusama, {Eric R.} and Molenaar, {I. Quintus} and {van der Peet}, {Donald L.} and Poen, {Alexander C.} and Rutger Quispel and Schaapherder, {Alexander F.} and Schoon, {Erik J.} and Schwartz, {Matthijs P.} and Seerden, {Tom C.} and Spanier, {B. W. Marcel} and Straathof, {Jan Willem} and Venneman, {Niels G.} and {van de Vrie}, Wim and Witteman, {Ben J.} and {van Goor}, Harry and Paul Fockens and {van Santvoort}, {Hjalmar C.} and Besselink, {Marc G.} and {Dutch Pancreatitis Study Grp}",

year = "2019",

month = apr,

day = "25",

doi = "10.1186/s13063-019-3315-6",

language = "English",

volume = "20",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

}

van Grinsven, J, van Dijk, SM, Dijkgraaf, MG, Boermeester, MA, Bollen, TL, Bruno, MJ, van Brunschot, S, Dejong, CH, van Eijck, CH, van Lienden, KP, Boerma, D, van Duijvendijk, P, Hadithi, M, Haveman, JW, van der Hulst, RW, Jansen, JM, Lips, DJ, Manusama, ER, Molenaar, IQ, van der Peet, DL, Poen, AC, Quispel, R, Schaapherder, AF, Schoon, EJ, Schwartz, MP, Seerden, TC, Spanier, BWM, Straathof, JW, Venneman, NG, van de Vrie, W, Witteman, BJ, van Goor, H, Fockens, P, van Santvoort, HC, Besselink, MG & Dutch Pancreatitis Study Grp 2019, 'Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial', Trials, vol. 20, 239. https://doi.org/10.1186/s13063-019-3315-6

TY - JOUR

T1 - Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial)

T2 - study protocol for a randomized controlled trial

AU - van Grinsven, Janneke

AU - van Dijk, Sven M.

AU - Dijkgraaf, Marcel G.

AU - Boermeester, Marja A.

AU - Bollen, Thomas L.

AU - Bruno, Marco J.

AU - van Brunschot, Sandra

AU - Dejong, Cornelis H.

AU - van Eijck, Casper H.

AU - van Lienden, Krijn P.

AU - Boerma, Djamila

AU - van Duijvendijk, Peter

AU - Hadithi, Muhammed

AU - Haveman, Jan Willem

AU - van der Hulst, Rene W.

AU - Jansen, Jeroen M.

AU - Lips, Daan J.

AU - Manusama, Eric R.

AU - Molenaar, I. Quintus

AU - van der Peet, Donald L.

AU - Poen, Alexander C.

AU - Quispel, Rutger

AU - Schaapherder, Alexander F.

AU - Schoon, Erik J.

AU - Schwartz, Matthijs P.

AU - Seerden, Tom C.

AU - Spanier, B. W. Marcel

AU - Straathof, Jan Willem

AU - Venneman, Niels G.

AU - van de Vrie, Wim

AU - Witteman, Ben J.

AU - van Goor, Harry

AU - Fockens, Paul

AU - van Santvoort, Hjalmar C.

AU - Besselink, Marc G.

AU - Dutch Pancreatitis Study Grp

PY - 2019/4/25

Y1 - 2019/4/25

N2 - 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.

AB - 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.

KW - Necrotizing pancreatitis

KW - Infection

KW - Step-up approach

KW - Timing

KW - Drainage

KW - Complication

KW - Randomized controlled trial

KW - STEP-UP APPROACH

KW - PERCUTANEOUS CATHETER DRAINAGE

KW - CLOSED PACKING

KW - NECROSECTOMY

KW - CLASSIFICATION

KW - INTERVENTION

KW - DEBRIDEMENT

KW - EXPERIENCE

KW - MANAGEMENT

KW - STERILE

U2 - 10.1186/s13063-019-3315-6

DO - 10.1186/s13063-019-3315-6

M3 - Article

C2 - 31023380

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 239

ER -