Effect of More Distal Enteral Bypass After Pancreaticoduodenectomy: A Prospective Multicenter Randomized Clinical Trial
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
1 other identifier
interventional
90
1 country
1
Brief 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. 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.
Trial Health
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedOctober 5, 2016
October 1, 2016
3.9 years
December 18, 2012
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of diabetes
Remission of diabetes 1. Pre-operative diabetics -\> post-operative non-diabetics 2. Pre-operative impaired fasting glucose -\> post-operative normal fasting glucose
One year after operation
Study Arms (1)
Standard pancreaticoduodenectomy
NO INTERVENTIONCases receiving pancreaticoduodenectomy with standard enteral bypass
Interventions
Patients undergoing pancreaticoduodenectomy, the enteral bypass (gastrojejunostomy/duodenojejunostomy is extra 100 cm away from standard bypass )
Eligibility Criteria
You may qualify if:
- Patients with impaired fasting glucose before operation
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National taiwan University Hospital
Taipei, Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Wen Tien, M.D. PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 24, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2016
Last Updated
October 5, 2016
Record last verified: 2016-10