The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical Trial

Plain-language guide to NCT03398941: not phased interventional trial of Octreotide, gum disease (periodontal) & oral health, 150 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03398941
Phase: not phased
Status: status unknown
Start: 2018-02-01
Completion (planned or actual): 2019-01-01
Participants: 150 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Pancreatic Diseases
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Octreotide for gum disease (periodontal) & oral health and pancreatitis (after the acute phase).

The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide on the Complications After Pancreatectomy.

A Prospective, Multicenter Clinical Trial.

It had 1 arm (groups): Combined group (experimental).

The registry classes the interventions as drug.

More on the Plan

The trial is funded by Cancer Foundation of China.

The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: every participant is enrolled or excluded by two practiced investigators.

And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: treated by chemotherapy or radiotherapy before with distant organ metastasis cannot tolerate surgery.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Octreotide study: the gum disease (periodontal) & oral health participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-02-01 with completion listed for 2019-01-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): pancreatic fistula (time frame: three week after operation). delayed gastric emptying (time frame: three week after operation). intra-abdominal fluid collections (time frame: three week after operation).

What This Means in Plain Language

Put simply, this is a not phased trial of Octreotide in 150 people with gum disease (periodontal) & oral health.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Gum disease (periodontal) & oral health research, Pancreatitis (after the acute phase) research.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.