UMIN-ICDS Clinical Trial

Public title

Prospective interventional study of postoperative high-fiber diet and perioperative outcomes after pulmonary resection

Acronym

POST-FIBER Lung Study

Scientific Title

A single-center prospective interventional study evaluating the safety, tolerability, and perioperative impact of early postoperative high-fiber diet after pulmonary resection

Scientific Title:Acronym

POST-FIBER Lung Study

Region

Japan

Condition

Primary lung cancer, metastatic lung tumors, and other pulmonary diseases for which pulmonary resection is indicated.

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to explore whether early postoperative oral intake with a defined amount of dietary fiber is associated with reduced perioperative complications and improved short- to mid-term recovery after pulmonary resection, including preservation of body weight and physical function. The study also focuses on the potential biological effects of early dietary fiber intake on efferocytosis, gut microbiota modulation, and perioperative immune responses.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of postoperative pulmonary complications, including pneumonia, atelectasis, acute respiratory distress syndrome, empyema, respiratory failure, reintubation, and mechanical ventilation for more than 48 hours.

Key secondary outcomes

Secondary endpoints include percentage change in postoperative body weight, percentage change in postoperative pulmonary function, change in postoperative activities of daily living, rate of decrease in postoperative inflammatory response, perioperative dietary intake rate, and percentage change in postoperative muscle mass.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food	Behavior,custom

Interventions/Control_1

An in-hospital dietary intervention using an early postoperative high-fiber diet and dietary guidance after discharge will be provided. Specifically, a high-fiber diet will be initiated from the evening of the day of surgery, and dietary fiber intake will be promoted during hospitalization using fiber-enriched meals and/or fiber supplements. From postoperative day 1 to postoperative day 4, dietary intake, abdominal symptoms, bowel habits, and adverse events will be assessed. After discharge, patients will receive dietary guidance focused on a high-fiber diet for approximately two weeks, and dietary intake and tolerability will be evaluated.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled to undergo elective pulmonary resection for primary lung cancer, metastatic lung tumors, or other pulmonary diseases for which pulmonary resection is indicated.
Patients scheduled to undergo pulmonary resection, including lobectomy, segmentectomy, or wedge resection.
Any surgical approach, including video-assisted thoracoscopic surgery, robot-assisted thoracic surgery, or open thoracotomy, is permitted.
Patients who can be managed according to a perioperative care protocol, including an ERAS protocol, in which oral intake is initiated on the day of surgery.
Patients who have received a sufficient explanation of the study and provided written informed consent.
Patients aged 18 years or older.
Patients with an ECOG Performance Status of 0, 1.

Key exclusion criteria

Patients scheduled to undergo pneumonectomy.
Patients scheduled to undergo highly invasive concomitant procedures that are expected to substantially affect the timing, safety, or evaluation of postoperative oral intake, such as extensive bronchoplasty or combined resection of adjacent organs.
Patients in whom the safety of study diet intake cannot be ensured because of dysphagia, a history of recurrent aspiration pneumonia, or other relevant conditions.
Patients who are expected preoperatively to require enteral tube feeding or total parenteral nutrition as the main route of nutritional management.
Patients with known allergy to the study diet or any of its components.
Patients with a history of colitis or inflammatory bowel disease.
Patients who underwent gastrointestinal surgery within 3 months before enrollment.
Patients with a history of total colectomy.
Patients with poorly controlled diabetes mellitus.
Patients who received systemic antibiotics within 21 days before surgery.
Patients receiving continuous systemic corticosteroid therapy.
Patients who used probiotics, prebiotics, or supplements that may affect the gut microbiota within 14 days before surgery and are unable to discontinue them.
Patients with dietary habits, such as a strict vegan diet, that are judged to substantially interfere with the standardized dietary intervention or dietary intake assessment.
Patients judged by the principal investigator or sub-investigators to be unsuitable for participation in the study because of cognitive impairment, social circumstances, difficulty with adherence, safety concerns, or other reasons.

Target sample size

60

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Takamori

Organization

Yamagata University Hospital

Division name

Department of Surgery II

Zip code

9909585

Address

2-2-2 Iida-Nishi, Yamagata City, Yamagata

TEL

0236285342

Email

s-takamori@med.id.yamagata-u.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Takamori

Organization

Yamagata University Hospital

Division name

Department of Surgery II

Zip code

9909585

Address

2-2-2 Iida-Nishi, Yamagata City, Yamagata

TEL

0236285342

Homepage URL

Email

s-takamori@med.id.yamagata-u.ac.jp

Institute

Yamagata University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yamagata Uviversity Hospital

Address

2-2-2 Iida-Nishi, Yamagata City, Yamagata

Tel

0236285342

Email

s-takamori@med.id.yamagata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

21

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

05

Month

22

Day

Last modified on

2026

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070541