TissueLink Versus SEAMGUARD After Distal Pancreatectomy (PLATS)

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Distal Pancreatectomy

Treatments: Device: SEAMGUARD with bioabsorbable staple; Procedure: TissueLink with radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01051856

09-000362

Details and patient eligibility

About

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.

Full description

The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure.

Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Age equal or above 18 years
2. Accepted for elective distal pancreatectomy for any indication

Exclusion from randomization process:

• 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.

General study exclusion criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

SEAMGUARD with bioabsorbable staple

Active Comparator group

Description:

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.

Treatment:

Device: SEAMGUARD with bioabsorbable staple

TissueLink with radiofrequency ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: TissueLink with radiofrequency ablation