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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00671463
Other study ID # 2007P000965
Secondary ID
Status Withdrawn
Phase N/A
First received May 1, 2008
Last updated June 10, 2013
Start date April 2008

Study information

Verified date June 2013
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients (greater than or equal to 18 years of age)

- Scheduled to undergo an elective laparoscopic or open distal pancreatectomy

- Willing to undergo pre-operative endoscopy

- Consenting to the procedure

Exclusion Criteria:

- Contraindication to abdominal surgery

- Contraindication to general anesthesia or distal pancreatectomy

- Contraindication to upper endoscopy or ERCP

- Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP

- Ongoing pancreatitis

- Pancreatic necrosis or abscess

- History of sphincter of Oddi dysfunction

- History of ERCP-induced pancreatitis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Procedure:
Pancreatic duct stenting
In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital American Society for Gastrointestinal Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pancreatic leak Post-operative day 3 No
Secondary Peritoneal fluid analysis Daily No
Secondary Serum biochemical analysis Daily No
Secondary Clinical outcomes Daily No
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