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PANasta Trial Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy – a double blinded multi centred trial

PANASTA

PANasta Trial Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy – a double blinded multi centred trial
Funding CRUK
Portfolio Cancer
Interventions Surgery
Randomised Yes
Status Analysis/reporting
Start Date 23-Apr-2015

Background:
Pancreas cancer is currently the 9th most common cancer in the UK, but accounts for the
5th highest cause of cancer related death; leading to an overall survival in the UK of only 4%
at 5 years. This regrettably is in part due to the fact that 70-80% of patients have advanced
or metastatic disease at presentation, which precludes cure. The best chance of long-term
survival to the remaining 20-30% of patients is Surgery with adjuvant chemotherapy, which in
this group offers 5-year survivals reaching almost 30%. Despite centralization of pancreatic
services morbidity still remains high, in spite of technological advances a major cause for
this is failure of the pancreatic anastomosis to heal. The literature quotes a pancreatic leak /
fistula rate in excess of 20% following pancreato-duodenectomy. These leaks increase the
overall mortality, complication rate, length of stay, cost and most importantly the ability of
such patients to receive adjuvant treatment within the desirable therapeutic window, which
will effect survival. An improved method of anastomosis “Blumgart” (BA) rather than “Cattell-
Warren” (CWA) should reduce pancreatic leaks, decrease hospital stay, shorten recovery,
reduce cost and increase quality adjusted survival.
Aims:
This study will assess reconstruction of the pancreatic remnant following
pancreatoduodenectomy. 2 methods of pancreatico-jejunostomy will be compared, CWA vs.
BA. This study will evaluate any benefit of the BA in terms of pancreatic anastomotic leak,
post operative collections, length of hospital stay and cost in terms of quality adjusted
survival.
Methods:
Prospective randomized, controlled, observer and patient blinded, multi-centre surgical trial
with two parallel study groups. Arm A=BA, Arm B=CWA. The primary end point will assess
the presence/absence of an anastomotic leak following Surgery. Secondary end points: Entry
into adjuvant treatment, mortality rate, morbidity rate, rate of post-operative collections,
operation time, rate of intra and post operative bleeding, delayed gastric emptying, venous
thrombo-embolism, hospital stay and non-surgical events will be assessed by clinical
parameters and by quality of life/economic evaluation questionnaires’’ (EORTEC QLQ-C30
and Eq-5D respectively).
How the results of this research will be used:
Results from this trial will be disseminated in high impact peer-reviewed journals. Adopting
an improved method of pancreatic reconstruction by the wider pancreatic surgical
community has the potential to make significant improvements in patient’s lives.

Publications

  • Halloran, C. M., Platt, K., Gerard, A., Polydoros, F., O'Reilly, D. A., Gomez, D., . . . Ghaneh, P. (2016). PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial. TRIALS, 17. doi:10.1186/s13063-015-1144-9
    1. https://doi.org/10.1186/s13063-015-1144-9