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Effect of More Distal Enteral Bypass After Pancreaticoduodenectomy: A Prospective Multicenter Randomized Clinical Trial

NCT01755273 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-10-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Pancreaticoduodenectomy with more distal enteral bypass

Patients undergoing pancreaticoduodenectomy, the enteral bypass (gastrojejunostomy/duodenojejunostomy is extra 100 cm away from standard bypass )

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yu-Wen Tien, M.D. PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-12-31

Countries

  • Taiwan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755273 on ClinicalTrials.gov