Acute Lower Gastrointestinal BleedingNCT03098173

Comparing Early Versus Elective Colonoscopy

A study testing Early colonoscopy and Elective colonoscopy in people with Acute Lower Gastrointestinal Bleeding, run by Tokyo University at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This multi-center, randomized controlled trial study is planned to include 162 outpatients with onset of acute lower gastrointestinal bleeding to compare the rate of identification of stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day rebleeding rate, between 'early' colonoscopy and… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Acute Lower Gastrointestinal Bleeding
What is being tested?: Early colonoscopy and Elective colonoscopy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 15 sitesJapan
Study dates: 29 Jan 2016to 4 Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.

Who cannot join

An individual who meets any of the following criteria will be excluded from participation in this study:
Patients with hematemesis, black vomiting, or melena.
Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
Patients who have impossible consumed the oral bowel preparation solution.
Patients who have undergone computed tomography.
Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.

Show all 19Show fewer

Ulcerative colitis or Crohn's disease patients.
Patients who have undergone abdominal surgery within the previous 10 days.
Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days.
Patients with suspected perforation or peritonitis.
Patients with suspected intestinal obstruction.
Patients with hemorrhagic shock refractory to infusion or blood transfusion.
Patients who have undergone total colectomy.
Patients with suspected disseminated intravascular coagulation.
Patients with end-stage malignant disease.
Patients with severe cardiac failure.
Patients with active thrombosis.
Patients with severe respiratory failure.
Pregnant patients.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

The University of Tokyo
Bunkyo-ku, Tokyo
St. Luke's International Hospital
Chuo-ku, Tokyo
Fukui prefectural hospital
Fukui-shi, Fukui
Japan Community Healthcare Organization Osaka Hospital
Fukushima-shi, Osaka
National Hospital Organization Hakodate Hospital
Hakodate-shi, Hokkaido
Hirosaki University Hospital
Hirosaki-shi, Aomori
National Center for Global Health and Medicine kohnodai hospital
Ichikawa-shi, Chiba
Ishikawa prefectural central hospital
Kanazawa, Ishikawa-ken
Nagasaki Harbor Medical Center City Hospital
Nagasaki, Nagasaki
Aichi Cancer Center Hospital
Nagoya, Aichi-ken
Otaru Ekisaikai Hospital
Otaru-shi, Hokkaido
Tonan Hospital
Sapporo, Hokkaido
National Center for Global Health and Medicine center hospital
Shinjuku-ku, Tokyo
Toyonaka Municipal Hospital
Toyonaka-shi, Osaka
Shuto General Hospital
Yanai-shi, Yamaguchi

Other trials in Japan

About this study

Official title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding

Read the detailed description

All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing.

Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.

Conditions: Acute Lower Gastrointestinal Bleeding
Being tested: Early colonoscopy, Elective colonoscopy
Keywords: Early colonoscopy, Stigmata of recent hemorrhage, Rebleeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early colonoscopyProcedure or surgery
Performance of prepared colonoscopy within 24 h of arrival
Elective colonoscopyProcedure or surgery
Performance of prepared colonoscopy between 24 and 96 h after arrival

Study groups in NCT03098173
Study group	Role	What they receive
Early colonoscopy	Experimental	Performance of prepared colonoscopy within 24 h of arrival Receives: Procedure: Early colonoscopy
Elective colonoscopy	Active comparator	Performance of prepared colonoscopy between 24 and 96 h after arrival Receives: Procedure: Elective colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Stigmata of Recent Hemorrhage (SRH) Identification Rate
Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.
Measured: 0-4 day

Secondary outcomes (11)

Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.
Measured: 0-4 day
Need for Additional Endoscopic Examinations
Additional endoscopic examinations will be defined as examinations to achieve hemostasis.
Measured: 0-34 day
Need for Interventional Radiology
It will be defined as radiology intervention to achieve hemostasis.
Measured: 0-34 day
Need for Surgery
It will be defined as surgery to achieve hemostasis.
Measured: 0-34 day
Thirty-day Rebleeding Rates
Rebleeding will be defined as significant fresh blood loss after an initial colonoscopy with any of the following criteria:
1. Hemorrhagic shock, including cold sweat, nausea, syncope, or systolic blood pressure ≤ 90 mmHg. ii) Need for transfusion, according to the guidelines of the Ministry of Health, Labour, and Welfare. iii) Further colonoscopy identifies blood pooling, or iv) SRH in the lower gastrointestinal tract. v) Contrast-enhanced CT identifies extravasation in the colorectal region. However, these examinations will not be performed routinely if rebleeding occurs in the study period.
Measured: 30 day
Need for Transfusion During Hospitalization
It will be defined as the numbers of patients who will need transfusion.
Measured: During hospitalization
Length of Stay
It will be defined as length of stay to cure acute lower gastrointestinal bleeding.
Measured: 0-34 day
Number of Participants With Thirty-day Thrombosis Events
Thrombosis events will include acute coronary syndromes, including angina pectoris and myocardial infarction, stroke, including cerebrovascular infarction, cerebral hemorrhage, and transient ischemic attacks, deep vein thrombosis, and pulmonary embolism.
Measured: 30 day
Number of Participants With Thirty-day Death Events
Number of Participants with Thirty-day death Events from enrollment
Measured: 30 day
Number of Participants With Preparation-related Adverse Events
Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus
Measured: 0-4 day
Number of Participants With Colonoscopy-related Adverse Events
Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.
Measured: 0-4 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 20164 Jan 2019

First posted31 Mar 2017
Study start29 Jan 2016
Primary completion24 Aug 2018
Study completion4 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Lower Gastrointestinal BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel, randomized, superiority trial
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03098173
Sponsor's protocol ID: P2015034-11Y
Other IDs: UMIN000021129
Status last verified: Oct 2019
First submitted: 26 Mar 2017
Last updated: 8 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Niikura R, Nagata N, Doyama H, Ota R, Ishii N, Mabe K, Nishida T, Hikichi T, Sumiyama K, Nishikawa J, Uraoka T, Kiyotoki S, Fujishiro M, Koike K. Current state of practice for colonic diverticular bleeding in 37 hospitals in Japan: A multicenter questionnaire study. World J Gastrointest Endosc. 2016 Dec 16;8(20):785-794. doi: 10.4253/wjge.v8.i20.785.
PubMed 28042393
Niikura R, Nagata N, Yamada A, Honda T, Hasatani K, Ishii N, Shiratori Y, Doyama H, Nishida T, Sumiyoshi T, Fujita T, Kiyotoki S, Yada T, Yamamoto K, Shinozaki T, Takata M, Mikami T, Mabe K, Hara K, Fujishiro M, Koike K. Efficacy and Safety of Early vs Elective Colonoscopy for Acute Lower Gastrointestinal Bleeding. Gastroenterology. 2020 Jan;158(1):168-175.e6. doi: 10.1053/j.gastro.2019.09.010. Epub 2019 Sep 26.
PubMed 31563627
Niikura R, Nagata N, Yamada A, Doyama H, Shiratori Y, Nishida T, Kiyotoki S, Yada T, Fujita T, Sumiyoshi T, Hasatani K, Mikami T, Honda T, Mabe K, Hara K, Yamamoto K, Takeda M, Takata M, Tanaka M, Shinozaki T, Fujishiro M, Koike K. A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):214. doi: 10.1186/s13063-018-2558-y.
PubMed 29615078

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
ClinicalTrials.gov ID: NCT03098173
Acronym / sponsor ID: P2015034-11Y
Conditions: Acute Lower Gastrointestinal Bleeding
Keywords: Early colonoscopy, Stigmata of recent hemorrhage, Rebleeding
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Tokyo UniversityUniversity, hospital or other
Study start: 29 Jan 2016 (actual)
Primary completion: 24 Aug 2018 (actual)
Study completion: 4 Jan 2019 (actual)
First posted: 31 Mar 2017 (actual)
Results: Posted 8 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing.

Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel, randomized, superiority trial

Arm	Type	Receives
Early colonoscopy	Experimental	Procedure: Early colonoscopyPerformance of prepared colonoscopy within 24 h of arrival
Elective colonoscopy	Active comparator	Procedure: Elective colonoscopyPerformance of prepared colonoscopy between 24 and 96 h after arrival

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.

Key exclusion criteria (19 listed)

An individual who meets any of the following criteria will be excluded from participation in this study:
Patients with hematemesis, black vomiting, or melena.
Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
Patients who have impossible consumed the oral bowel preparation solution.
Patients who have undergone computed tomography.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early colonoscopyPerformance of prepared colonoscopy within 24 h of arrival	Procedure or surgery	Early colonoscopy
Elective colonoscopyPerformance of prepared colonoscopy between 24 and 96 h after arrival	Procedure or surgery	Elective colonoscopy

Primary outcome

Stigmata of Recent Hemorrhage (SRH) Identification Rate
Time frame: 0-4 day
Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.

11 secondary outcomes

Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment
Time frame: 0-4 day
Need for Additional Endoscopic Examinations
Time frame: 0-34 day
Need for Interventional Radiology
Time frame: 0-34 day
Need for Surgery
Time frame: 0-34 day
Thirty-day Rebleeding Rates
Time frame: 30 day
Need for Transfusion During Hospitalization
Time frame: During hospitalization
Length of Stay
Time frame: 0-34 day
Number of Participants With Thirty-day Thrombosis Events
Time frame: 30 day
Number of Participants With Thirty-day Death Events
Time frame: 30 day
Number of Participants With Preparation-related Adverse Events
Time frame: 0-4 day
Number of Participants With Colonoscopy-related Adverse Events
Time frame: 0-4 day

Results and safety

Results posted to the registry on 8 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elective Colonoscopy	81	80
Early Colonoscopy	81	79

Primary outcome: Stigmata of Recent Hemorrhage (SRH) Identification Rate

Time frame: 0-4 day. Count of participants. Unit: Participants

Measure	Early Colonoscopy n = 79	Elective Colonoscopy n = 80
Value	17	17

Population analysed: The primary analysis included a modified intention-to-treat population, excluding the following patients from the genuine intention-to-treat analysis set: 1) those who did not satisfy the enrollment criteria after randomization; 2) those who provided no post-randomization data on primary outcome; and 3) those who did not undergo colonoscopy

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Colonoscopy	2 of 79 (2.5%)	9 of 79 (11.4%)	0 of 79
Elective Colonoscopy	0 of 80 (0%)	8 of 80 (10%)	0 of 80

Limitations and caveats (from the sponsor): Non blinding

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28042393Niikura R, Nagata N, Doyama H, Ota R, Ishii N, Mabe K, Nishida T, Hikichi T, Sumiyama K, Nishikawa J, Uraoka T, Kiyotoki S, Fujishiro M, Koike K. Current state of practice for colonic diverticular bleeding in 37 hospitals in Japan: A multicenter questionnaire study. World J Gastrointest Endosc. 2016 Dec 16;8(20):785-794. doi: 10.4253/wjge.v8.i20.785.
Derived from this study: PubMed 31563627Niikura R, Nagata N, Yamada A, Honda T, Hasatani K, Ishii N, Shiratori Y, Doyama H, Nishida T, Sumiyoshi T, Fujita T, Kiyotoki S, Yada T, Yamamoto K, Shinozaki T, Takata M, Mikami T, Mabe K, Hara K, Fujishiro M, Koike K. Efficacy and Safety of Early vs Elective Colonoscopy for Acute Lower Gastrointestinal Bleeding. Gastroenterology. 2020 Jan;158(1):168-175.e6. doi: 10.1053/j.gastro.2019.09.010. Epub 2019 Sep 26.
Derived from this study: PubMed 29615078Niikura R, Nagata N, Yamada A, Doyama H, Shiratori Y, Nishida T, Kiyotoki S, Yada T, Fujita T, Sumiyoshi T, Hasatani K, Mikami T, Honda T, Mabe K, Hara K, Yamamoto K, Takeda M, Takata M, Tanaka M, Shinozaki T, Fujishiro M, Koike K. A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):214. doi: 10.1186/s13063-018-2558-y.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Atsuo Yamada, MD study director

Tokyo University

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Early colonoscopy and Elective colonoscopy in people with Acute Lower Gastrointestinal Bleeding, run by Tokyo University at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stigmata of Recent Hemorrhage (SRH) Identification Rate (time frame: 0-4 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098173, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.