Trial Outcomes & Findings for Treatment of IPF With Laparoscopic Anti-Reflux Surgery (NCT NCT01982968)

NCT ID: NCT01982968

Last Updated: 2021-10-25

Results Overview

Change in FVC (in liters) between enrollment and 48 weeks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Baseline and 48 weeks
• Results posted on: 2021-10-25

Participant Flow

Participant milestones

Measure	Control Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER
Overall Study STARTED	29	29
Overall Study COMPLETED	21	27
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of IPF With Laparoscopic Anti-Reflux Surgery

Baseline characteristics by cohort

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER	Total n=58 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 7.35 • n=5 Participants	70.6 years STANDARD_DEVIATION 5.97 • n=7 Participants	69.9 years STANDARD_DEVIATION 6.67 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 48 weeks

Population: Randomized patients

Change in FVC (in liters) between enrollment and 48 weeks.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Forced Vital Capacity (FVC)	-0.13 liters Interval -0.23 to -0.02	-0.05 liters Interval -0.15 to 0.05

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always).

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks Do you get heartburn?	-0.65 score on a scale Standard Deviation 1.09	-1.04 score on a scale Standard Deviation 0.95
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks Does your stomach get bloated?	-0.40 score on a scale Standard Deviation 0.82	-0.39 score on a scale Standard Deviation 0.99
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks Do you get bitter liquid (acid) in throat?	-0.63 score on a scale Standard Deviation 1.01	-1.13 score on a scale Standard Deviation 0.90
Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks Do you burp a lot?	-0.25 score on a scale Standard Deviation 0.72	-0.74 score on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: 48 weeks

Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Safety of Laparoscopic Anti-reflux Surgery All Cause Mortality	4 Participants	1 Participants
Safety of Laparoscopic Anti-reflux Surgery Serious Adverse Events	8 Participants	5 Participants
Safety of Laparoscopic Anti-reflux Surgery Other (Not Including Serious) Adverse Events	0 Participants	9 Participants

SECONDARY outcome

Timeframe: 48 weeks

Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
All-cause Mortality	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Impact on non-elective hospitalizations from baseline to 48 weeks.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Non-elective Hospitalization	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Impact on acute exacerbations of IPF from baseline to week 48.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Acute Exacerbations	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score	0.69 score on a scale Interval -6.24 to 4.86	0.71 score on a scale Interval -5.62 to 4.21

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
St. George's Respiratory Questionnaire (SGRQ) Score	-3.18 score on a scale Interval -8.35 to 1.99	1.04 score on a scale Interval -3.66 to 5.74

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Change in 6-minute walk distance from baseline to week 48

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
6-minute Walk Distance	9.13 meters Interval -14.77 to 33.02	16.54 meters Interval -4.8 to 37.88

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough.

Outcome measures

Measure	Control n=29 Participants Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 Participants Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)
Cough Visual Analog Scale (VAS)	7.15 score on a scale Interval -2.01 to 16.31	4.74 score on a scale Interval -3.14 to 12.63

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: Data are not available to be reported due to inability to obtain imaging data on participants and generate a score.

Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 8 serious events

Other events: 0 other events

Deaths: 4 deaths

Surgery

Serious events: 5 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Control n=29 participants at risk Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 participants at risk Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER
Respiratory, thoracic and mediastinal disorders Respiratory Worsening	17.2% 5/29 • Number of events 5 • 48 weeks	6.9% 2/29 • Number of events 2 • 48 weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Cardiac disorders acute myocardial infarction	0.00% 0/29 • 48 weeks	6.9% 2/29 • Number of events 2 • 48 weeks
Cardiac disorders cardiac disorder	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Cardiac disorders myocardial infarction	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Gastrointestinal disorders gastrointestinal haemorrhave	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Gastrointestinal disorders intestinal obstruction	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Hepatobiliary disorders bile duct obstruction	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Gastrointestinal disorders cholecytitis	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Infections and infestations pneumonia	6.9% 2/29 • Number of events 2 • 48 weeks	0.00% 0/29 • 48 weeks
Infections and infestations sepsis	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Blood and lymphatic system disorders anaemia	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung cancer metastatic	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Nervous system disorders carotid artery stenosis	3.4% 1/29 • Number of events 1 • 48 weeks	0.00% 0/29 • 48 weeks
Vascular disorders shock	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks

Other adverse events

Measure	Control n=29 participants at risk Subjects to receive standard anti-reflux treatment per clinical discretion	Surgery n=29 participants at risk Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER
Gastrointestinal disorders dysphagia	0.00% 0/29 • 48 weeks	13.8% 4/29 • Number of events 4 • 48 weeks
Gastrointestinal disorders abdominal distension	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Gastrointestinal disorders flatulence	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Gastrointestinal disorders gastrointestinal haemorrhage	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Gastrointestinal disorders gastrointestinal motility disorder	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Gastrointestinal disorders nausea	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Injury, poisoning and procedural complications incision site pain	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks
Metabolism and nutrition disorders dehydration	0.00% 0/29 • 48 weeks	3.4% 1/29 • Number of events 1 • 48 weeks

Additional Information

Harold Collard, MD

University of California, San Francisco

Phone: 415 4761000

Email: Harold.Collard@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place