Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: The multicentre, randomised, controlled, double-blind ChroPac trial
The Lancet Sep 21, 2017
Diener MK, et al. - In a multicentre, randomised, controlled trial, researchers compared the long-term (24 months) postoperative outcomes of patients with chronic pancreatitis who underwent duodenum-preserving pancreatic head resection (DPPHR) or partial pancreatoduodenectomy. Both the interventions did not differ in terms of quality of life after surgery. Results from single-centre trials showing superiority for DPPHR were not confirmed in the multicentre setting.
Methods
- Researchers performed a randomised, controlled, double-blind, parallel-group, superiority trial in 18 hospitals across Europe.
- They randomly assigned chronic pancreatitis patients who were planned for elective surgical treatment to DPPHR or partial pancreatoduodenectomy with a central web-based randomisation tool.
- Mean quality of life within 24 months after surgery was the primary endpoint, which was measured with the physical functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire.
- All patients who underwent one of the assigned procedures were included in the primary analysis; all patients who underwent surgical intervention (categorised into groups as treated) were included in safety analysis.
- Patients and outcome assessors were masked to group assignment.
Results
- The final analysis included 226 patients (115 in the DPPHR group and 111 in the partial pancreatoduodenectomy group).
- Neither the quality of life differ between the groups within 24 months after surgery (75·3 [SD 16·4] for partial pancreatoduodenectomy vs 73·0 [16·4] for DPPHR; mean difference -2·3, 95% CI -6·6 to 2·0; p=0·284), nor the incidence and severity of serious adverse events.
- Data reported that 70 (64%) of 109 patients in the DPPHR group and 61 (52%) of 117 patients in the partial pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoperations (for reasons other than chronic pancreatitis), gastrointestinal problems, and other surgical morbidity.
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