Reflux EsophagitisNCT01311908
Incidence of Reflux Esophagitis After Pancreaticoduodenectomy
An observational study of Reflux Esophagitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- Methods of gastrojejunostomy reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tudy the effect of a Roux-en-Y reconstruction on GERD and marginal ulcer after pancreaticoduodenectomy
Who may be able to join
- age greater than 18 years and planned PD for a lesion of either the pancreatic head or the periampullary region
Who cannot join
- history of abdominal or pelvic radiation
- hepatic dysfunction (Child-Pugh > 2)
- renal dysfunction (serum creatinine concentration > 3 mg/L, hemodialysis, or both)
- cardiac dysfunction (New York Heart Association functional class > III, stroke history)
- pregnancy
- history of intestinal anastomosis of the large bowel without a diverting stoma
Trial locations and contacts
1 site in 1 country.
Yu-Wen Tien, M.D., Ph.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Wen Tien
Yu-Wen Tien
About this study
Official title: Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy
Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study, the investigators will investigate the incidence of reflux esophagitis after above procedure by the 24-h pH monitoring of esophagogastric junction.
Read the detailed description
Reflux esophagitis is a common complication following distal gastrectomy. Recently, an Roux-en--Y gastrointestinal reconstruction has been used increasingly to prevent reflux esophagitis; however, reflux esophagitis after pancreaticoduodenectomy (also including distal gastrectomy) has never been studied.
In our preliminary retrospective study of 371 patients having PD (158 standard PD and 213 pylorus-preserving PD) at our hospital, after a median follow-up of 20 months (range, 2-110 months), 40 patients (10.8%) developed reflux esophagitis - 15 (9.5%) in the standard PD group, and 25 (11.7%) in the PPPD group. Multivariate logistic regression analysis revealed the only significant factors related to reflux esophagitis is Roux-en-Y gastrointestinal reconstruction independent of preservation of the pylorus.
To our surprise, there is no significant difference in occurrence of GERD between patients after standard PD (15 of 158 patient) and PPPD (25 of 313 patients, P=0.49). We postulate reflux esophagitis following a PPPD in patients without past history of GERD is most likely caused by disruption of reflux-preventing systems at the gastroesophageal junction, thereby allowing reflux of gastric acid into esophagus. If the postulation is true, GERD after PPPD should be acidic in nature. To test this hypothesis we propose a prospective randomized study to compare preoperative and postoperative parameters, including esophageal morphology, bile acid concentration, trypsin activity of esophageal refluxate, COX2 mRNA expression of lower esophageal mucosa, and 24 hour pH monitor of lower esophagus.
Moreover, to test the effect of a Roux-en-Y reconstruction to prevent GERD after PD, studied patients will be randomized into Roux-en-Y and control groups to study inter-group differences in incidence of GERD and marginal ulcer after PD.
Acidic GERD should be treated with proton pump inhibitor. In contrast, alkaline GERD should be treated with pro-kinetic agent such as primperan and mopride. With this study, we can learn more about the nature of post-PD GERD following various gastrointestinal reconstructions and can give patient more personalized therapy.
- Conditions
- Reflux Esophagitis
- Being tested
- Methods of gastrojejunostomy reconstruction
- Keywords
- Pancreaticoduodenectomy, Roux-en-Y reconstruction, Reflux esophagitis
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methods of gastrojejunostomy reconstructionProcedure or surgery
Also called Reconstruction of gastrojejunostomy, Roux-en-Y anastomosis versus gastrojejunostomy only
Roux-en-Y reconstruction in pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgery, Roux-en-Y , reflux esophagitis | Patients with roux-en-Y reconstruction (study group) Receives: Procedure: Methods of gastrojejunostomy reconstruction | |
| surgery, traditional gastrojejunostomy | Traditional gastrojejunostomy reconstruction (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of reflux esophagitis
Use panendiscopy to assess the reflux esopagitis
Measured: 3 months
Secondary outcomes (1)
Incidenc of marginal ulcer
Use endoscopy to assess the marginal ulcer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Wen Tien, M.D., Ph.D., Principal investigator, Department of surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311908
- Sponsor's protocol ID
- 201005058R
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01311908
- Acronym / sponsor ID
- 201005058R
- Conditions
- Reflux Esophagitis
- Keywords
- Pancreaticoduodenectomy, Roux-en-Y reconstruction, Reflux esophagitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Mar 2011 (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.
Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study, the investigators will investigate the incidence of reflux esophagitis after above procedure by the 24-h pH monitoring of esophagogastric junction.
Detailed description
Reflux esophagitis is a common complication following distal gastrectomy. Recently, an Roux-en--Y gastrointestinal reconstruction has been used increasingly to prevent reflux esophagitis; however, reflux esophagitis after pancreaticoduodenectomy (also including distal gastrectomy) has never been studied.
In our preliminary retrospective study of 371 patients having PD (158 standard PD and 213 pylorus-preserving PD) at our hospital, after a median follow-up of 20 months (range, 2-110 months), 40 patients (10.8%) developed reflux esophagitis - 15 (9.5%) in the standard PD group, and 25 (11.7%) in the PPPD group. Multivariate logistic regression analysis revealed the only significant factors related to reflux esophagitis is Roux-en-Y gastrointestinal reconstruction independent of preservation of the pylorus.
To our surprise, there is no significant difference in occurrence of GERD between patients after standard PD (15 of 158 patient) and PPPD (25 of 313 patients, P=0.49). We postulate reflux esophagitis following a PPPD in patients without past history of GERD is most likely caused by disruption of reflux-preventing systems at the gastroesophageal junction, thereby allowing reflux of gastric acid into esophagus. If the postulation is true, GERD after PPPD should be acidic in nature. To test this hypothesis we propose a prospective randomized study to compare preoperative and postoperative parameters, including esophageal morphology, bile acid concentration, trypsin activity of esophageal refluxate, COX2 mRNA expression of lower esophageal mucosa, and 24 hour pH monitor of lower esophagus.
Moreover, to test the effect of a Roux-en-Y reconstruction to prevent GERD after PD, studied patients will be randomized into Roux-en-Y and control groups to study inter-group differences in incidence of GERD and marginal ulcer after PD.
Acidic GERD should be treated with proton pump inhibitor. In contrast, alkaline GERD should be treated with pro-kinetic agent such as primperan and mopride. With this study, we can learn more about the nature of post-PD GERD following various gastrointestinal reconstructions and can give patient more personalized therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery, Roux-en-Y , reflux esophagitis | – | Procedure: Methods of gastrojejunostomy reconstructionPatients with roux-en-Y reconstruction (study group) |
| surgery, traditional gastrojejunostomy | – | –Traditional gastrojejunostomy reconstruction (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tudy the effect of a Roux-en-Y reconstruction on GERD and marginal ulcer after pancreaticoduodenectomy
Key inclusion criteria (1 listed)
- age greater than 18 years and planned PD for a lesion of either the pancreatic head or the periampullary region
Key exclusion criteria (6 listed)
- history of abdominal or pelvic radiation
- hepatic dysfunction (Child-Pugh > 2)
- renal dysfunction (serum creatinine concentration > 3 mg/L, hemodialysis, or both)
- cardiac dysfunction (New York Heart Association functional class > III, stroke history)
- pregnancy
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 |
|---|---|---|
| Methods of gastrojejunostomy reconstructionAlso: Reconstruction of gastrojejunostomy, Roux-en-Y anastomosis versus gastrojejunostomy onlyRoux-en-Y reconstruction in pancreaticoduodenectomy | Procedure or surgery | Surgery, Roux-en-Y , reflux esophagitis |
Primary outcome
Incidence and severity of reflux esophagitis
Time frame: 3 months
Use panendiscopy to assess the reflux esopagitis
1 secondary outcome
Incidenc of marginal ulcer
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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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.
Yu-Wen Tien, M.D., Ph.D. contact
Yu-Wen Tien, M.D., Ph.D. 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?
An observational study of Reflux Esophagitis, 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 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 23 Mar 2011. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Wen Tien, M.D., Ph.D. (Ywtien5106@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of reflux esophagitis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2011.