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Randomized Controlled Trial
. 2024 Apr 1;279(4):671-678.
doi: 10.1097/SLA.0000000000006001. Epub 2023 Jul 17.

Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER): Multicenter Randomized Trial

Charlotte L Van Veldhuisen  1   2   3 , Noor J Sissingh  3   4 , Lotte Boxhoorn  2   5 , Sven M van Dijk  1   2 , Janneke van Grinsven  1   2 , Robert C Verdonk  6 , Marja A Boermeester  1   2 , Stefan A W Bouwense  7 , Marco J Bruno  8 , Vincent C Cappendijk  9 , Peter van Duijvendijk  10 , Casper H J van Eijck  11 , Paul Fockens  2   5 , Harry van Goor  12 , Muhammed Hadithi  13 , Jan Willem Haveman  14 , Maarten A J M Jacobs  15 , Jeroen M Jansen  16 , Marnix P M Kop  2   17 , Eric R Manusama  18 , J Sven D Mieog  19 , I Quintus Molenaar  20 , Vincent B Nieuwenhuijs  21 , Alexander C Poen  22 , Jan-Werner Poley  23 , Rutger Quispel  24 , Tessa E H Römkens  25 , Matthijs P Schwartz  26 , Tom C Seerden  27 , Marcel G W Dijkgraaf  28 , Martijn W J Stommel  12 , Jan Willem A Straathof  29 , Niels G Venneman  30 , Rogier P Voermans  2   5 , Jeanin E van Hooft  4 , Hjalmar C van Santvoort  31   32 , Marc G Besselink  1   2 ; Dutch Pancreatitis Study Group
Affiliations
Randomized Controlled Trial

Long-Term Outcome of Immediate Versus Postponed Intervention in Patients With Infected Necrotizing Pancreatitis (POINTER): Multicenter Randomized Trial

Charlotte L Van Veldhuisen et al. Ann Surg. .

Abstract

Objective: To compare the long-term outcomes of immediate drainage versus the postponed-drainage approach in patients with infected necrotizing pancreatitis.

Background: In the randomized POINTER trial, patients assigned to the postponed-drainage approach using antibiotic treatment required fewer interventions, as compared with immediate drainage, and over a third were treated without any intervention.

Methods: Clinical data of those patients alive after the initial 6-month follow-up were re-evaluated. The primary outcome was a composite of death and major complications.

Results: Out of 104 patients, 88 were re-evaluated with a median follow-up of 51 months. After the initial 6-month follow-up, the primary outcome occurred in 7 of 47 patients (15%) in the immediate-drainage group and 7 of 41 patients (17%) in the postponed-drainage group (RR 0.87, 95% CI 0.33-2.28; P =0.78). Additional drainage procedures were performed in 7 patients (15%) versus 3 patients (7%) (RR 2.03; 95% CI 0.56-7.37; P =0.34). The median number of additional interventions was 0 (IQR 0-0) in both groups ( P =0.028). In the total follow-up, the median number of interventions was higher in the immediate-drainage group than in the postponed-drainage group (4 vs. 1, P =0.001). Eventually, 14 of 15 patients (93%) in the postponed-drainage group who were successfully treated in the initial 6-month follow-up with antibiotics and without any intervention remained without intervention. At the end of follow-up, pancreatic function and quality of life were similar.

Conclusions: Also, during long-term follow-up, a postponed-drainage approach using antibiotics in patients with infected necrotizing pancreatitis results in fewer interventions as compared with immediate drainage and should therefore be the preferred approach.

Trial registration: ISRCTN33682933.

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Conflict of interest statement

M.G.B.: grants from Ethicon Endo-Surgery and Medtronic. M.A.B. grants from Ipsen, New Compliance, Mylan, grants and personal fees from Johnson & Johnson, Acelity/KCI, and personal fees from Bard, Gore, Smith & Nephew. M.J.B.: consultant for Boston Scientific, Cook Medical, and Pentax Medical, financial support from Boston Scientific, Cook Medical, Pentax Medical, InterScope, 3M, and Mylan. P.F.: personal fees from Cook Medical, Ethicon Endo-surgery, and Olympus Medical. J.E.v.H.: grants and personal fees from Prion Medical, Cook Medical, and Olympus. J.P.: personal and other fees from Cook Endoscopy, Boston Scientific, and Pentax Medical. R.P. Voermans: grants and personal fees from Boston Scientific and grants from Zambon. All financial relationships were outside the submitted work. The remaining authors no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Trial Profile.
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References

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