Clinical trial · Interventional
Laser Tissue Welding - Distal Pancreatectomy Sealing Study
Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding
NCT03147768CI-TRIAL-00057616LTWcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure. The hypothesis is that the laser tissue welding device is safe and effective in sealing the pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic juice leakage for patients when the Laser Tissue Welding device is used after pancreatic resection.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Injury | — | UNRESOLVED | — |
| Pancreas; Insulinoma | — | UNRESOLVED | — |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cyst | — | UNRESOLVED | — |
| Pancreatic Cystadenoma | — | UNRESOLVED | — |
| Pancreatic Gastrinoma | Pancreatic Gastrinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Glucagonoma | Pancreatic Glucagonoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Distal Pancreatectomy Sealing Using LTW | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Distal Pancreatectomy Sealing using LTW
- description
- At the completion of pancreatic resection, the cut surface of the pancreas is covered with two layers of Albu-Green solder and one layer of D-Albumin lamina, all welded with the laser. The 60 Watt custom 810nm diode laser, is set to deliver continuous energy with laser irradiation power of approximately 150 W/cm2 with a Fluence of 90 J/cm2. During soldering the tip of the custom hand piece with top hat beam profile is held 1-2 cm from the wound surface to generate a 5mm spot size. Albu-Green Solder is observed to convert from a liquid green state to a solid white crust when the laser is activated indicating the completion of welding and providing a visual cue to the operator. The amount of Albu-Green solder and size of the denatured albumin lamina used is documented. The total laser tissue welding time for the three layers and the laser tissue welding time in seconds per cm2 is documented.
- interventionNames
- Device: Distal Pancreatectomy Sealing Using LTW
Primary outcomes (1)
- measure
- PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss
- timeFrame
- Intra-operative
- description
- Operative blood loss is defined by: volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use. Clinical drop in hemoglobin (1 gm% = 300 ml) without hemodilution. Correlates with intra-operative blood transfusions. Correlates with post-operative blood transfusions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Eligible participants will be 18 years and older of both genders. 1. T1a (≤ 4 cm, as measured by the maximal dimension by CT or MRI). Final determination of disease stage is made during the operation by the investigator. All resectable cystic, benign, primary or secondary malignant tumors. 2. Serum creatinine: ≤ 2.5 mg/dL 3. Glomerular filtration rate greater than ≥ 50 ml/min/m2 4. Platelet count ≥ 50,000/mm3 5. Prothrombin time \< 18 seconds 6. PTT not \>1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions \[e.g., atrial fibrillation\]); 7. Serum albumin levels \> 3g/dL (Normal range 3.5 to 5 g/dL) Exclusion Criteria: 1. Age younger than 18 years' old 2. Severe uncorrected hypertension (\> 180 systolic and \>110 diastolic) 3. Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox) 4. Pregnancy 5. Females who are breast feeding who do not switch the infant to formula prior to surgery 6. Active urinary tract infection 7. T1b (\>4 cm) lesion and above 8. Systemic or local infection. 9. Subject has known allergy or intolerance to iodine or human serum albumin. 10. Recent febrile illness that precludes or delays participation preoperatively. 11. Treatment with another investigational drug or other intervention during the study and follow-up period. 12. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
References
Publications (4)
- BACKGROUNDKleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb. PMID 17414606
- BACKGROUNDGoh BK. Re: Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2008 Feb;247(2):392-3; author reply 393. doi: 10.1097/SLA.0b013e318164022d. No abstract available. PMID 18216551
- BACKGROUNDKazanjian KK, Hines OJ, Duffy JP, Yoon DY, Cortina G, Reber HA. Improved survival following pancreaticoduodenectomy to treat adenocarcinoma of the pancreas: the influence of operative blood loss. Arch Surg. 2008 Dec;143(12):1166-71. doi: 10.1001/archsurg.143.12.1166. PMID 19075167
- BACKGROUNDShrikhande SV, D'Souza MA. Pancreatic fistula after pancreatectomy: evolving definitions, preventive strategies and modern management. World J Gastroenterol. 2008 Oct 14;14(38):5789-96. doi: 10.3748/wjg.14.5789. PMID 18855976