Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

What Was Tested

This registered phase 3 trial tested Octreotide.

It had two arms (groups): Blumgart Anastomosis (experimental) and Cattell-Warren Anastomosis (active comparator).

Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy. Octreotide will be administered.

Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy. Octreotide will be administered.

The registry classes the interventions as drug and procedure.

More on the Plan

This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus.

Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.

Patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon: Arm A: Blumgart method of panreaticojejunostomy.

Arm B: CattellWarren method pf pancreaticojejunostomy.

Who Took Part

The registry lists 295 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients undergoing an elective pancreato-duodenectomy for presumed malignancy. Ability of the subject to understand the nature and consequences of the trial. Ability to rovide writen informed consent. Age 18 or greater.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: patients undergoing extended pancreato-duodenectomy; left, central or total pancreatectomy; arterial resection or multi-visceral resection.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2015-04-23 with completion listed for 2018-07-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Presence or absence of post-operative pancreatic fistula (time frame: Assessed up to 3 months after surgery).

It also tracked 13 secondary outcomes, for example Entry into programs of adjuvent therapy, Mortality Rate, Rate of delayed gastric emptying, Rate of wound infections, Rate of pulmonary infection and Rate of post-operative fluid collections.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 295 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.