A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery: study protocol for a randomized controlled trial

What Was Tested

The paper reports a study of ANP (Atrial Natriuretic Peptide), published as a randomized controlled trial.

The objective of this study is to evaluate the effects of ANP on the incidence of postoperative cancer recurrence in lung cancer surgery.

Why It Was Studied

Postoperative cancer recurrence is a major problem following curative surgery.

UMIN Clinical Trials Registry identifier: UMIN000018480 .

Who Took Part

The study group was 500 patients.

The present study is a multicenter, randomized trial with two parallel groups of patients with lung cancer comparing surgery alone and surgery with ANP administration for 3 days during the perioperative period.

A total of 500 patients will be enrolled from 10 Japanese institutions.

How the Study Was Run

The researchers set it up as a randomized, multicenter and parallel-group study.

Because people in this ANP (Atrial Natriuretic Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Running at several centres spread the ANP (Atrial Natriuretic Peptide) study over different clinics and patient groups.

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

The timeline in the abstract includes 3 days.

The primary endpoint is 2-year relapse-free survival (RFS).

The secondary endpoints are 2-year cancer-specific RFS, 5-year RFS, overall survival, the incidence of postoperative complications, and the completion rate of ANP treatment.

What Was Measured

The subject headings attached to it are Antineoplastic Agents, Atrial Natriuretic Factor, Chemotherapy, Adjuvant, Clinical Protocols, Disease-Free Survival, Japan and Kaplan-Meier Estimate.

Author keywords: Atrial natriuretic peptide, Cancer recurrence, Lung cancer surgery and Perioperative care.

What This Means in Plain Language

The paper is a randomized, multicenter and parallel-group study of ANP (Atrial Natriuretic Peptide) in 500 patients over 3 days.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 1 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2017 (Trials), a journal based in England.

More context: the ANP (Atrial Natriuretic Peptide) compound page, all human trials.