Esophageal Anastomotic StricturePhase 1NCT02703376
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
A Phase 1 study testing Oral Prednisone in people with Esophageal Anastomotic Stricture, run by Nagasaki University at 1 site in Japan.
Trial summary
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Esophageal Anastomotic Stricture
- What is being tested?
- Oral Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2016to Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who develop the severe esophageal strictures from 28 days after esophageal surgery
Who cannot join
- Pulmonary and cardiac disorders
- Liver and renal dysfunctions
- Allergic
- Pregnancy
- infectious disease
- Unsuitable condition
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nagasaki University
Nagasaki, Nagasaki, 852-8501
Kobayashi Shinichiro, M.D., +81958197316, shinichirokobayashi@nagasaki-u.ac.jp
About this study
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
Read the detailed description
Esophageal strictures are common complications after surgery and aggressive endoscopic submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However, patients, who develop esophageal strictures after extensive operations, usually develop refractory strictures. Although there are several treatments for refractory strictures, their utility is limited.
Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have shown the safety and potential efficacy to prevent esophageal strictures after ESD. However, the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after esophageal surgery.
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
- Conditions
- Esophageal Anastomotic Stricture
- Being tested
- Oral Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PrednisoneDrug
Also called prednisolone
Intakes of Oral Prednisone for 12 weeks after balloon dilations
| Study group | Role | What they receive |
|---|---|---|
| Patients after esophageal surgery | Other | Oral Prednisone for 12 weeks Receives: Drug: Oral Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification
Measured: for 12 weeks after the intervention
Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0
physical conditions, clinical laboratory abnormalities, and ECG abnormalities
Measured: for 12 weeks after the intervention
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
Measured: for 12 weeks after the intervention
Secondary outcomes (4)
Rate of re-strictures at 85 postoperative days
Measured: for 12 weeks after the intervention
Number of participants with endoscopic classification of strictures before intervention
Measured: before the intervention
Dysphagia score
Measured: for 12 weeks after the intervention
Session of the dilatation
Measured: for 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal Anastomotic StrictureStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kobayashi Shinichiro, Nagasaki University
- Investigators
- Kobayashi Shinichiro, Study director, Department of Surgery Nagasaki University Graduate School of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703376
- Sponsor's protocol ID
- NagasakiU2
- Status last verified
- Mar 2016
- First submitted
- 18 Jan 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14.
PubMed 21492854Kobayashi S, Kanai N, Ohki T, Takagi R, Yamaguchi N, Isomoto H, Kasai Y, Hosoi T, Nakao K, Eguchi S, Yamamoto M, Yamato M, Okano T. Prevention of esophageal strictures after endoscopic submucosal dissection. World J Gastroenterol. 2014 Nov 7;20(41):15098-109. doi: 10.3748/wjg.v20.i41.15098.
PubMed 25386058
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
- ClinicalTrials.gov ID
- NCT02703376
- Acronym / sponsor ID
- NagasakiU2
- Conditions
- Esophageal Anastomotic Stricture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
Detailed description
Esophageal strictures are common complications after surgery and aggressive endoscopic submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However, patients, who develop esophageal strictures after extensive operations, usually develop refractory strictures. Although there are several treatments for refractory strictures, their utility is limited.
Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have shown the safety and potential efficacy to prevent esophageal strictures after ESD. However, the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after esophageal surgery.
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after esophageal surgery | Other | Drug: Oral PrednisoneOral Prednisone for 12 weeks |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who develop the severe esophageal strictures from 28 days after esophageal surgery
Key exclusion criteria (6 listed)
- Pulmonary and cardiac disorders
- Liver and renal dysfunctions
- Allergic
- Pregnancy
- infectious disease
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 |
|---|---|---|
| Oral PrednisoneAlso: prednisoloneIntakes of Oral Prednisone for 12 weeks after balloon dilations | Drug | Patients after esophageal surgery |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification
Time frame: for 12 weeks after the intervention
Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0
Time frame: for 12 weeks after the intervention
physical conditions, clinical laboratory abnormalities, and ECG abnormalities
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
Time frame: for 12 weeks after the intervention
4 secondary outcomes
Rate of re-strictures at 85 postoperative days
Time frame: for 12 weeks after the intervention
Number of participants with endoscopic classification of strictures before intervention
Time frame: before the intervention
Dysphagia score
Time frame: for 12 weeks after the intervention
Session of the dilatation
Time frame: for 12 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 21492854Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14.
- Background: PubMed 25386058Kobayashi S, Kanai N, Ohki T, Takagi R, Yamaguchi N, Isomoto H, Kasai Y, Hosoi T, Nakao K, Eguchi S, Yamamoto M, Yamato M, Okano T. Prevention of esophageal strictures after endoscopic submucosal dissection. World J Gastroenterol. 2014 Nov 7;20(41):15098-109. doi: 10.3748/wjg.v20.i41.15098.
- Individual participant dataSharing planned: No
Related trials for Esophageal Anastomotic Stricture
Not yet recruitingPhase 1/2
Esophageal Replacement With a Decellularized Human Esophagus Graft
Esophageal Stenosis
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.
Kobayashi Shinichiro study director
Department of Surgery Nagasaki University Graduate School of Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Prednisone in people with Esophageal Anastomotic Stricture, run by Nagasaki University at 1 site 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kobayashi Shinichiro, M.D. (+81958197316, skobayashi1980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification (time frame: for 12 weeks after the intervention). The study lists 3 primary outcomes in all. 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 NCT02703376, which also lists 2 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 9 Mar 2016.