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ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial.

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM - Trials (2010)

Bottom Line: A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland.Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery.Level of significance is set at 5% (two-sided) and sample size (n = 100 per group) is determined to assure a power of 90%.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Heidelberg, Department of General, Visceral and Transplantation Surgery, Heidelberg, Germany.

ABSTRACT

Background: A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed.

Methods/design: ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy) in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided) and sample size (n = 100 per group) is determined to assure a power of 90%.

Discussion: The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system). Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis.

Trial registration: Controlled-trials.com ISRCTN38973832.

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Related in: MedlinePlus

ChroPac study flow.
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Figure 2: ChroPac study flow.

Mentions: 13 centres with high-level expertise for pancreatic surgery will contribute to recruitment of study patients. The duration of the trial for each participant is expected to be about 2 years. The duration of the overall trial is expected to be 5 years, including prearrangement and analysis. Recruitment of participants started in April 2009. The process of the trial conduct is illustrated in Figure 2.


ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial.

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM - Trials (2010)

ChroPac study flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2874785&req=5

Figure 2: ChroPac study flow.
Mentions: 13 centres with high-level expertise for pancreatic surgery will contribute to recruitment of study patients. The duration of the trial for each participant is expected to be about 2 years. The duration of the overall trial is expected to be 5 years, including prearrangement and analysis. Recruitment of participants started in April 2009. The process of the trial conduct is illustrated in Figure 2.

Bottom Line: A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland.Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery.Level of significance is set at 5% (two-sided) and sample size (n = 100 per group) is determined to assure a power of 90%.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Heidelberg, Department of General, Visceral and Transplantation Surgery, Heidelberg, Germany.

ABSTRACT

Background: A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed.

Methods/design: ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy) in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided) and sample size (n = 100 per group) is determined to assure a power of 90%.

Discussion: The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system). Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis.

Trial registration: Controlled-trials.com ISRCTN38973832.

Show MeSH
Related in: MedlinePlus