Anastomotic LeakagePhase 2NCT00942526
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
A Phase 2 study testing Mycostatin oral suspension and Water in people with Anastomotic Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Anastomotic Leakage
- What is being tested?
- Mycostatin oral suspension and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- carcinoma of the esophagus, operable stage I to III
Who cannot join
- patients who were inoperable,
- patients who had obvious impaired blood supply of gastric substitutes, and
- patients who had non-cervical esophagogastrostomy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Pei-Ming Huang, MD, +886-2-23123456 ext. 63509, e370089@gmail.com
Pei-Ming Huang, MD
About this study
Official title: The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.
Read the detailed description
Goal:
The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing.
Method:
- Design: One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent. An end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. On the other hand, the anastomotic leakage rates in different groups will be investigated.
- Data Collection and Statistic Analysis:
The records of all patients, various biologic parameters, and the management of leakage are analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. Time variation of starting oral feeding and hospital stay are compared using the Kaplan-Meier method.
- Conditions
- Anastomotic Leakage
- Being tested
- Mycostatin oral suspension, Water
- Keywords
- esophageal cancer, anastomotic leakage, Prevention of anastomotic leakage after esophageal surgery
- Medical subject headings
- Anastomotic Leak, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycostatin oral suspensionDrug
peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days
WaterOther
perioperative gargling with water
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | no intervention with perioperative oral anti-infective agent or water for gargling |
| 2 | Sham comparator | perioperative gargling with water Receives: Other: Water |
| 3 | Experimental | perioperative oral gargling with oral anti-infective agent for seven days Receives: Drug: Mycostatin oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause anastomotic leakage
Measured: two years
Secondary outcomes (1)
Time variation of starting oral feeding and hospital stay
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pei-Ming Huang, MD, Principal investigator, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942526
- Sponsor's protocol ID
- 200806035R
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5.
PubMed 6865459Roy-Choudhury SH, Nicholson AA, Wedgwood KR, Mannion RA, Sedman PC, Royston CM, Breen DJ. Symptomatic malignant gastroesophageal anastomotic leak: management with covered metallic esophageal stents. AJR Am J Roentgenol. 2001 Jan;176(1):161-5. doi: 10.2214/ajr.176.1.1760161.
PubMed 11133560Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. doi: 10.1007/BF00316817.
PubMed 8091778Peracchia A, Bardini R, Ruol A, Asolati M, Scibetta D. Esophagovisceral anastomotic leak. A prospective statistical study of predisposing factors. J Thorac Cardiovasc Surg. 1988 Apr;95(4):685-91.
PubMed 3280882Dewar L, Gelfand G, Finley RJ, Evans K, Inculet R, Nelems B. Factors affecting cervical anastomotic leak and stricture formation following esophagogastrectomy and gastric tube interposition. Am J Surg. 1992 May;163(5):484-9. doi: 10.1016/0002-9610(92)90393-6.
PubMed 1575303Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.
PubMed 1548890
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00942526
- Acronym / sponsor ID
- 200806035R
- Conditions
- Anastomotic Leakage
- Keywords
- esophageal cancer, anastomotic leakage, Prevention of anastomotic leakage after esophageal surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 21 Jul 2009 (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.
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.
Detailed description
Goal:
The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing.
Method:
- Design: One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent. An end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. On the other hand, the anastomotic leakage rates in different groups will be investigated.
- Data Collection and Statistic Analysis:
The records of all patients, various biologic parameters, and the management of leakage are analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. Time variation of starting oral feeding and hospital stay are compared using the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –no intervention with perioperative oral anti-infective agent or water for gargling |
| 2 | Sham comparator | Other: Waterperioperative gargling with water |
| 3 | Experimental | Drug: Mycostatin oral suspensionperioperative oral gargling with oral anti-infective agent for seven days |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- carcinoma of the esophagus, operable stage I to III
Key exclusion criteria (3 listed)
- patients who were inoperable,
- patients who had obvious impaired blood supply of gastric substitutes, and
- patients who had non-cervical esophagogastrostomy.
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 |
|---|---|---|
| Mycostatin oral suspensionperoperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days | Drug | 3 |
| Waterperioperative gargling with water | Other | 2 |
Primary outcome
all cause anastomotic leakage
Time frame: two years
1 secondary outcome
Time variation of starting oral feeding and hospital stay
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
- Background: PubMed 6865459Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5.
- Background: PubMed 11133560Roy-Choudhury SH, Nicholson AA, Wedgwood KR, Mannion RA, Sedman PC, Royston CM, Breen DJ. Symptomatic malignant gastroesophageal anastomotic leak: management with covered metallic esophageal stents. AJR Am J Roentgenol. 2001 Jan;176(1):161-5. doi: 10.2214/ajr.176.1.1760161.
- Background: PubMed 8091778Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. doi: 10.1007/BF00316817.
- Background: PubMed 3280882Peracchia A, Bardini R, Ruol A, Asolati M, Scibetta D. Esophagovisceral anastomotic leak. A prospective statistical study of predisposing factors. J Thorac Cardiovasc Surg. 1988 Apr;95(4):685-91.
- Background: PubMed 1575303Dewar L, Gelfand G, Finley RJ, Evans K, Inculet R, Nelems B. Factors affecting cervical anastomotic leak and stricture formation following esophagogastrectomy and gastric tube interposition. Am J Surg. 1992 May;163(5):484-9. doi: 10.1016/0002-9610(92)90393-6.
- Background: PubMed 1548890Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.
- National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)Link provided by the sponsor.
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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.
Pei-Ming Huang, MD principal investigator
Department of Surgery, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycostatin oral suspension and Water in people with Anastomotic Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 21 Jul 2009. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Pei-Ming Huang, MD (+886-2-23123456 ext. 63509, e370089@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause anastomotic leakage (time frame: two years). 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 NCT00942526, which also lists 6 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 21 Jul 2009.