External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)

Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01634971

Acronym

EDIDPD

Enrollment

120

Registered

2012-07-06

Start date

2012-05-31

Completion date

2016-12-31

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Surgical and Medical Care: General Terms, Postoperative Fistula

Keywords

Postoperative pancreatic fistula(POPF);, Postpancreatectomy hemorrhage(PPH);, Delayed gastric emptying (DGE);, Bile leakage after pancreatic surgery;, Anastomotic leakage

Brief summary

Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.

Detailed description

The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).

Interventions

PROCEDUREInternal Drainage of Pancreatic Duct after pancreatomy

the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age more than 18 years. * Received pancreatoduodenectomy. * Informed consent has been signed.

Exclusion criteria

* Age less than 18 years * Emergency surgery * Past history of pancreatic surgery.

Design outcomes

Primary

Measure	Time frame	Description
the rate of Postoperative pancreatic fistula within 2 weeks after operation	within 2 weeks after operation	Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.

Secondary

Measure	Time frame	Description
the rate of postoperative Surgical Complications	2 weeks after operation	the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage

Countries

China

Contacts

Primary ContactQiang WU, MD. Ph.D.

wuqiangtianjin@hotmail.com18622221080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026