PancreaticoduodenectomyNCT01755273
Effect of More Distal Enteral Bypass After Pancreaticoduodenectomy: A Prospective Multicenter Randomized Clinical Trial
A study testing Pancreaticoduodenectomy with more distal enteral bypass in people with Pancreaticoduodenectomy and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas, proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was followed by complicated reconstructions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreaticoduodenectomy, Diabetes
- What is being tested?
- Pancreaticoduodenectomy with more distal enteral bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DM
- Patients with impaired fasting glucose before operation
Who cannot join
- Type 1 diabetes
- History of pancreatitis
- Hepatic dysfunction (Child-Pugh > 2)
- Renal dysfunction (serum creatinine concentration > 3 mg/L, hemodialysis, or both)
- Pregnancy
- Malnutrition (pre-operative BMI <20)
Trial locations and contacts
1 site in 1 country.
Yu-Wen Tien, M.D., PhD contact
Jin-Ming Wu, M.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
National taiwan University Hospital
Taipei, Taipei, 100
Jin-Ming Wu, M.D., kptkptkpt@yahoo.com.tw
Yu-Wen Tien, M.D. PhD
About this study
Official title: Compare More Distal Enteral Bypass With Standard Enteral Bypass in the Remission of Glucose Metabolism for Patients With Diabetes or Impaired Fasting Glucose After Pancreaticoduodenectomy: A Prospective Multicenter Randomized Clinical Trial
Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas, proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was followed by complicated reconstructions. Therefore, PD causes change of physiological functions, containing insufficiency of exocrine and endocrine pancreatic function, malabsorption of nutrients, impairment of gut peristalsis, and hepatic steatosis . On the other hand, DM may also resolve after PD in cases with pancreatic ductal adenocarcinoma. From the study of bariatric operation, resolution of DM may occur even before body weight loss. Postulated mechanism of resolution of DM after bariatric operation included foregut and hind gut theory. Actually, both hindgut and foregut effects on sugar control are achieved to some extent after pancreaticoduodenectomy. First, most of the duodenum is routinely removed in PD and there will be no food passage through duodenum (foregut theory) after PD. Second, proximal 10 cm of jejunum will be removed in PD and another 30~ 40 cm- long jejunum will be brought up for pancreatic and biliary anastomosis, which will make the last enteral anastomosis (gastrojejunostomy or duodenojejunostomy) be created at site about 50-60 cm distal to Treitz ligament. Therefore, food will directly pass into distal jejunum (hindgut theory). In our preliminary study, 35% patients have resolution of diabetes after PD, especially for ones with new-onset DM. Further, a prospective randomized clinical trial will be conducted to address if modified distal gastro-/duodeno-jejunostomy results in a higher proportion of diabetes remission compared with standard PD.
Read the detailed description
All new-onset DM patients undergoing PD will be considered for inclusion in this prospective randomized study. Inclusion criteria will be age greater than 20 years and planned PD for a lesion of either the pancreatic head or the periampullary region. The patients received standard PD are defined as control group; the cases receiving more distal gastro-/duodeno-jejunostomy ( 60 cm distal to gastro-/duodeno-jejunostomy on the control group) are defined as study group . The trial will be conducted only after obtaining an approval for the study design from the National Taiwan University institutional ethics review board. The type of surgery (pylorus-preserving or standard PD) and the type of management of the pancreatic stump (pancreaticojejunostomy or pancreaticogastrostomy) will be left to the surgeons' discretion. This trial will be done for two years to investigate if distal enteral bypass results in more remission of diabetes in new-onset DM cases after PD .After PD, FBG and HbA1c were routinely checked every 3 months for two years. The definition of remission of DM was that a fasting glucose level < 110 mg/dL and HbA1c < 6.0% without the use of oral hypoglycemic agents or insulin was defined as complete remission. A fasting glucose value < 126 mg/dL and HbA1c <6.5% was defined partial remission.32 In addition, the body weight will be checked regularly. The demographic, pathological, and clinical data will be recorded. The preoperative and postoperative antidiabetic medication and doses were also included.
In plan (to study if more distal bypass of gastrojejunostomy may increase remission of new-onset DM cases), the major concern of potential risk for patients participating the clinical trial is malnutrition due to enteral bypass. Other surgical procedures are the same as standard PD. For the monitoring of malnutrition, patients visited outpatient clinic every month for the first six months, and every three months afterward. The complete blood count and value of serum albumin will be checked very three months. The body weight loss > 10% during three months is considered malnutrition. The peripheral parenteral nutrition will be administered to manage the malnutrition, and total parenteral nutrition should be used if malnutrition persisted. However, malnutrition is also a common phenomenon for recurrent cancer cases. The management of malnutrition for cancer patients will be managed according to clinical guidelines at National Taiwan University Hospital.
- Conditions
- Pancreaticoduodenectomy, Diabetes
- Being tested
- Pancreaticoduodenectomy with more distal enteral bypass
- Keywords
- Pancreaticoduodenectomy, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy with more distal enteral bypassProcedure or surgery
Patients undergoing pancreaticoduodenectomy, the enteral bypass (gastrojejunostomy/duodenojejunostomy is extra 100 cm away from standard bypass )
| Study group | Role | What they receive |
|---|---|---|
| Standard pancreaticoduodenectomy | No intervention | Cases receiving pancreaticoduodenectomy with standard enteral bypass Receives: Procedure: Pancreaticoduodenectomy with more distal enteral bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of diabetes
Remission of diabetes
- Pre-operative diabetics -> post-operative non-diabetics
- Pre-operative impaired fasting glucose -> post-operative normal fasting glucose
Measured: One year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wen Tien, M.D. PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755273
- Sponsor's protocol ID
- 201203073RIC
- Status last verified
- Oct 2016
- First submitted
- 18 Dec 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare More Distal Enteral Bypass With Standard Enteral Bypass in the Remission of Glucose Metabolism for Patients With Diabetes or Impaired Fasting Glucose After Pancreaticoduodenectomy: A Prospective Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01755273
- Acronym / sponsor ID
- 201203073RIC
- Conditions
- Pancreaticoduodenectomy, Diabetes
- Keywords
- Pancreaticoduodenectomy, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 24 Dec 2012 (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.
Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas, proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was followed by complicated reconstructions. Therefore, PD causes change of physiological functions, containing insufficiency of exocrine and endocrine pancreatic function, malabsorption of nutrients, impairment of gut peristalsis, and hepatic steatosis . On the other hand, DM may also resolve after PD in cases with pancreatic ductal adenocarcinoma. From the study of bariatric operation, resolution of DM may occur even before body weight loss. Postulated mechanism of resolution of DM after bariatric operation included foregut and hind gut theory. Actually, both hindgut and foregut effects on sugar control are achieved to some extent after pancreaticoduodenectomy. First, most of the duodenum is routinely removed in PD and there will be no food passage through duodenum (foregut theory) after PD. Second, proximal 10 cm of jejunum will be removed in PD and another 30~ 40 cm- long jejunum will be brought up for pancreatic and biliary anastomosis, which will make the last enteral anastomosis (gastrojejunostomy or duodenojejunostomy) be created at site about 50-60 cm distal to Treitz ligament. Therefore, food will directly pass into distal jejunum (hindgut theory). In our preliminary study, 35% patients have resolution of diabetes after PD, especially for ones with new-onset DM. Further, a prospective randomized clinical trial will be conducted to address if modified distal gastro-/duodeno-jejunostomy results in a higher proportion of diabetes remission compared with standard PD.
Detailed description
All new-onset DM patients undergoing PD will be considered for inclusion in this prospective randomized study. Inclusion criteria will be age greater than 20 years and planned PD for a lesion of either the pancreatic head or the periampullary region. The patients received standard PD are defined as control group; the cases receiving more distal gastro-/duodeno-jejunostomy ( 60 cm distal to gastro-/duodeno-jejunostomy on the control group) are defined as study group . The trial will be conducted only after obtaining an approval for the study design from the National Taiwan University institutional ethics review board. The type of surgery (pylorus-preserving or standard PD) and the type of management of the pancreatic stump (pancreaticojejunostomy or pancreaticogastrostomy) will be left to the surgeons' discretion. This trial will be done for two years to investigate if distal enteral bypass results in more remission of diabetes in new-onset DM cases after PD .After PD, FBG and HbA1c were routinely checked every 3 months for two years. The definition of remission of DM was that a fasting glucose level < 110 mg/dL and HbA1c < 6.0% without the use of oral hypoglycemic agents or insulin was defined as complete remission. A fasting glucose value < 126 mg/dL and HbA1c <6.5% was defined partial remission.32 In addition, the body weight will be checked regularly. The demographic, pathological, and clinical data will be recorded. The preoperative and postoperative antidiabetic medication and doses were also included.
In plan (to study if more distal bypass of gastrojejunostomy may increase remission of new-onset DM cases), the major concern of potential risk for patients participating the clinical trial is malnutrition due to enteral bypass. Other surgical procedures are the same as standard PD. For the monitoring of malnutrition, patients visited outpatient clinic every month for the first six months, and every three months afterward. The complete blood count and value of serum albumin will be checked very three months. The body weight loss > 10% during three months is considered malnutrition. The peripheral parenteral nutrition will be administered to manage the malnutrition, and total parenteral nutrition should be used if malnutrition persisted. However, malnutrition is also a common phenomenon for recurrent cancer cases. The management of malnutrition for cancer patients will be managed according to clinical guidelines at National Taiwan University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard pancreaticoduodenectomy | No intervention | Procedure: Pancreaticoduodenectomy with more distal enteral bypassCases receiving pancreaticoduodenectomy with standard enteral bypass |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DM
- Patients with impaired fasting glucose before operation
Key exclusion criteria (6 listed)
- Type 1 diabetes
- History of pancreatitis
- Hepatic dysfunction (Child-Pugh > 2)
- Renal dysfunction (serum creatinine concentration > 3 mg/L, hemodialysis, or both)
- 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 |
|---|---|---|
| Pancreaticoduodenectomy with more distal enteral bypassPatients undergoing pancreaticoduodenectomy, the enteral bypass (gastrojejunostomy/duodenojejunostomy is extra 100 cm away from standard bypass ) | Procedure or surgery | Standard pancreaticoduodenectomy |
Primary outcome
Resolution of diabetes
Time frame: One year after operation
Remission of diabetes 1. Pre-operative diabetics -> post-operative non-diabetics 2. Pre-operative impaired fasting glucose -> post-operative normal fasting glucose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
Related trials for Pancreaticoduodenectomy
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
Recruiting
Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC)
Pancreatic Surgery, Prophylactic SBRT
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Pancreaticoduodenectomy
Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreatic Cancer, Periampullary Cancer
RecruitingPhase 3
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Pancreas Cancer, Periampullary Cancer
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., PhD contact
Jin-Ming Wu, M.D. contact
Yu-Wen Tien, M.D. PhD principal investigator
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 study testing Pancreaticoduodenectomy with more distal enteral bypass in people with Pancreaticoduodenectomy and Diabetes, 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 2 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 5 Oct 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 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., PhD (ywtien5106@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of diabetes (time frame: One year after operation). 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 5 Oct 2016.