Clinical trial NCT00889213: An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas
Official title: A Prospective Randomized Comparison of Pancreatic Stump Closure Techniques Utilizing an Autologous Falciform Patch and Fibrin Glue Compared to Standard Closure Following Distal Pancreatectomy With or Without Splenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Distal Pancreatectomy Complications
Falciform Patch Pancreatic Closure
Fibrin Glue Pancreatic Closure
Keywords: pancreatectomy
fistula
fibrin glue
falciform patch
surgery
complications
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).


Eligibility criteria: Inclusion Criteria:

1. completion of a successful distal pancreatectomy with/without splenectomy
2. patient must have a pancreatic remnant in place
3. there must be a viable falciform ligament for creation of the autologous patch

Exclusion Criteria:

1. patients undergoing total pancreatectomy
2. patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
3. failure to sign informed consent
4. pregnant patients
5. patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection

Primary outcomes:
measure: Pancreatic fistula development post distal pancreatectomy
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Morbidity- wound infection,delayed gastric emptying,abscess formation
timeFrame: 30 day
measure: Mortality
timeFrame: 30 day
measure: Surgical re-intervention/percutaneous interventions
timeFrame: 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Ernest L Rosato, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carter TI, Fong ZV, Hyslop T, Lavu H, Tan WP, Hardacre J, Sauter PK, Kennedy EP, Yeo CJ, Rosato EL. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? J Gastrointest Surg. 2013 Jan;17(1):102-9. doi: 10.1007/s11605-012-1963-x. Epub 2012 Jul 14.