Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.

Tarvainen T, Sirén J, Kokkola A, Sallinen V

JAMA surgery1 Apr 2020Cited by 49 (Europe PMC)

PMID32022887PMCIDPMC7042940DOI10.1001/jamasurg.2019.6019PepBankPUB-32022887

Summary

ImportanceBoth hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone.ObjectiveTo assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy.Design, setting, and participantsA noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results.InterventionsTreatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.Main outcomes and measuresThe primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points.ResultsOf the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.Conclusions and relevanceIn this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.Trial registrationClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
After partial pancreatectomy, mean CCI was 23.94 (SD 17.06) with pasireotide versus 30.11 (20.47) with hydrocortisone; difference -6.16 (90% CI -11.73 to -0.60).
In plain wordsAfter partial pancreatectomy, complication scores were lower with pasireotide than hydrocortisone, and hydrocortisone failed the noninferiority criterion.
Peptide
Pasireotide
Outcome
DecreaseComprehensive Complication Index within 30 days
Study
n = 126
Comparator
Hydrocortisone
Analysis
Primary
Outcome group
Surgical complications · Gastrointestinal
Studied dose
900 μg twice a day · subcutaneous · 7 daysAs given in this study (human).
Measurements
Mean CCI score
23.94 CCI points
pasireotide group; SD 17.06
Mean CCI score
30.11 CCI points
hydrocortisone group; SD 20.47
Mean difference in CCI score
−6.16 CCI points
as reported, pasireotide vs hydrocortisone
90% CI of mean difference in CCI score
−11.73 to −0.6 CCI points
2-sided 90% CI
Source sentences
Summary
The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.
2 context sentences(design, population, supporting numbers)
Summary · context
A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018.
Summary · context
Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Show in the study text Report a problemFND-3202288701
02HumanRandomized controlled trialEfficacy outcome
After partial pancreatectomy, fistula occurred in 34 (54%) pasireotide patients versus 39 (62%) hydrocortisone patients (reported OR 1.39, 95% CI 0.68-2.82; P=.37).
In plain wordsAfter partial pancreatectomy, fistula occurred less frequently with pasireotide than hydrocortisone, without a significant difference.
Peptide
Pasireotide
Outcome
DecreasePostoperative pancreatic fistula
Study
n = 126
Comparator
Hydrocortisone
Outcome group
Surgical complications · Gastrointestinal
Studied dose
900 μg twice a day · subcutaneous · 7 daysAs given in this study (human).
Measurements
Patients with postoperative pancreatic fistula
34 patients
pasireotide group
Proportion with postoperative pancreatic fistula
54%
pasireotide group
Patients with postoperative pancreatic fistula
39 patients
hydrocortisone group
Proportion with postoperative pancreatic fistula
62%
hydrocortisone group
Odds ratio for postoperative pancreatic fistula
1.39
as reported
95% CI of odds ratio
0.68 to 2.82
95% CI
P value
0.37
fistula comparison
Source sentences
Summary
Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37).
2 context sentences(design, population, supporting numbers)
Summary · context
A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018.
Summary · context
Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Show in the study text Report a problemFND-3202288702
03HumanRandomized controlled trialSafety outcome
After partial pancreatectomy, one pasireotide patient versus 2 hydrocortisone patients died within 30 days.
In plain wordsAfter partial pancreatectomy, one pasireotide patient and 2 hydrocortisone patients died within 30 days.
Peptide
Pasireotide
Outcome
DecreaseDeath within 30 days
Study
n = 126
Comparator
Hydrocortisone
Outcome group
Mortality · Whole body
Studied dose
900 μg twice a day · subcutaneous · 7 daysAs given in this study (human).
Measurements
Deaths within 30 days
1 patients
pasireotide group
Deaths within 30 days
2 patients
hydrocortisone group
Source sentences
Summary
One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days.
2 context sentences(design, population, supporting numbers)
Summary · context
A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018.
Summary · context
Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Show in the study text Report a problemFND-3202288703
04HumanRandomized controlled trialEfficacy outcome
After distal pancreatectomy, mean CCI was 16.03 (SD 11.94) with pasireotide versus 26.28 (21.76) with hydrocortisone, 10.3 points lower (95% CI -19.34 to -2.12; P=.03).
In plain wordsAfter distal pancreatectomy, pasireotide complication scores were 10.3 points lower than hydrocortisone scores.
Peptide
Pasireotide
Outcome
DecreaseDistal pancreatectomy CCI
Study
n: not reported in source
Comparator
Hydrocortisone
Outcome group
Surgical complications · Gastrointestinal
Studied dose
900 μg twice a day · subcutaneous · 7 daysAs given in this study (human).
Measurements
Mean CCI score, distal pancreatectomy subgroup
16.03 CCI points
pasireotide group; SD 11.94
Mean CCI score, distal pancreatectomy subgroup
26.28 CCI points
hydrocortisone group; SD 21.76
CCI points lower with pasireotide than hydrocortisone, distal pancreatectomy subgroup
10.3 CCI points
mean difference as stated
95% CI of CCI difference, distal pancreatectomy subgroup
−19.34 to −2.12 CCI points
2-sided 95% CI
P value
0.03
distal pancreatectomy subgroup CCI
Source sentences
Summary
In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03)
2 context sentences(design, population, supporting numbers)
Summary · context
A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018.
Summary · context
Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Show in the study text Report a problemFND-3202288704
05HumanRandomized controlled trialEfficacy outcome
After distal pancreatectomy, fistula rates were 37% with pasireotide versus 67% with hydrocortisone (P=.02).
In plain wordsAfter distal pancreatectomy, fistula rates were lower with pasireotide than hydrocortisone.
Peptide
Pasireotide
Outcome
DecreaseDistal pancreatectomy fistula rate
Study
n: not reported in source
Comparator
Hydrocortisone
Outcome group
Surgical complications · Gastrointestinal
Studied dose
900 μg twice a day · subcutaneous · 7 daysAs given in this study (human).
Measurements
Postoperative pancreatic fistula rate, distal pancreatectomy subgroup
37%
pasireotide group
Postoperative pancreatic fistula rate, distal pancreatectomy subgroup
67%
hydrocortisone group
P value
0.02
distal pancreatectomy subgroup fistula rate
Source sentences
Summary
and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.
2 context sentences(design, population, supporting numbers)
Summary · context
A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018.
Summary · context
Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Show in the study text Report a problemFND-3202288705

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 4NCT02775227

HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Helsinki University Central Hospitaln = 126May 2016 to est. Dec 2029

Pancreatic Fistula · Pancreatic Neoplasms

Trial page ClinicalTrials.govUpdated 24 Aug 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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