TissueLink Versus SEAMGUARD After Distal Pancreatectomy

NCT01051856 | Terminated Phase 4 Results DMC

• 1 other identifier: 09-000362
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.

Conditions

Distal Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation

  Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.

  90 days from the operation

Secondary Outcomes (1)

• Severity of the Pancreatic Fistula Leaks

  90 days post operative

Study Arms (2)

SEAMGUARD with bioabsorbable staple

ACTIVE COMPARATOR

In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing.

Device: SEAMGUARD with bioabsorbable staple

TissueLink with radiofrequency ablation

ACTIVE COMPARATOR

After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second.

Procedure: TissueLink with radiofrequency ablation

Interventions

SEAMGUARD with bioabsorbable staple DEVICE

In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.

SEAMGUARD with bioabsorbable staple

TissueLink with radiofrequency ablation PROCEDURE

After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.

TissueLink with radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or above 18 years
• Accepted for elective distal pancreatectomy for any indication
• Thickness of pancreas on preoperative CT scan images \> 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study.

You may not qualify if:

• Current immunosuppressive therapy
• Chemotherapy within 2 weeks before operation
• Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation
• Radiotherapy before operation
• Inability to follow the instructions given by the investigator
• Lack of compliance
• Persons unable or unwilling to give informed consent to participate in this study
• Pregnant women
• Prisoners
• Institutionalized individuals

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Massachusettes General Hospital

Boston, Massachusetts, 02144, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

  PMID: 16003309 BACKGROUND

• Shubert CR, Ferrone CR, Fernandez-Del Castillo C, Kendrick ML, Farnell MB, Smoot RL, Truty MJ, Que FG. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. J Surg Res. 2016 Nov;206(1):32-40. doi: 10.1016/j.jss.2016.06.034. Epub 2016 Jun 17.

  PMID: 27916372 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

The trial closed early due to poor accrual of subjects.

Results Point of Contact

• Title: Florencia G. Que, MD
• Organization: Mayo Clinic

que.florencia@mayo.edu

507-284-6178

Study Officials

• Florencia G Que, M.D. S

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 20, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 22, 2023
• Results First Posted: June 12, 2015

Record last verified: 2023-06

Locations

US (2)