Attachable Coolingbis® for Distal Pancreatectomy

Official title

Safety and Feasibility of Radiofrequency-Assisted Robotic Distal Pancreatectomy (Attachable Coolingbis®)

Overview

This pilot study evaluates the safety and technical feasibility of a new radiofrequency-assisted device, the Attachable Coolingbis® (ACB), when used during robotic distal pancreatectomy. Distal pancreatectomy, a common operation for tumors of the body or tail of the pancreas, carries a high risk of postoperative pancreatic fistula (occurring in 30-40% of cases) because standard stapling techniques often fail to achieve an effective biological seal of the pancreatic remnant. The ACB device applies radiofrequency energy to coagulate and seal the pancreatic tissue before transection, a technique that has shown promising results in laparoscopic surgery and in preclinical robotic testing. This study adapts the device for use on the robotic surgical platform for the first time in humans. Twenty adult patients undergoing robotic distal pancreatectomy for benign, premalignant, or malignant pancreatic tumors will be enrolled across four Spanish hospitals. All participants will receive the robotic procedure with the ACB device; there is no comparison group, as this is an exploratory, single-arm study. The main goal is to determine whether the device can be used safely and effectively, by monitoring serious adverse events, pancreatic fistula, bleeding, and other surgical complications occurring up to 90 days after surgery. Participants will also be followed for one year to assess longer-term outcomes, including pancreatic function, tumor recurrence, and quality of life.

Detailed description

Distal pancreatectomy (DP) accounts for 25-35% of all pancreatic resections and remains the standard approach for benign and malignant lesions of the pancreatic body and tail. Management of the pancreatic remnant after transection continues to be an unresolved surgical challenge: conventional stapling techniques fail to achieve a reliable biological seal, and clinically relevant postoperative pancreatic fistula (CR-POPF) develops in approximately 30-40% of cases, contributing substantially to postoperative morbidity, prolonged hospitalization, and increased healthcare costs.

Radiofrequency (RF)-assisted transection has emerged as a strategy to improve pancreatic stump sealing by inducing controlled coagulative necrosis of the parenchyma prior to division, promoting connective tissue collapse around ductal structures. This approach is supported by preclinical and clinical evidence, including a propensity-matched retrospective cohort showing a reduction in POPF incidence with the laparoscopic Coolingbis® device, and interim results from the multicenter randomized TRANSPAIRE trial (NCT04402346) suggesting a similar benefit. A robotic-adapted version of this technology, the Attachable Coolingbis® (ACB), has recently completed preclinical validation in a large-animal (porcine) model using a robotic platform, with no relevant adverse events observed among survivors followed to 30 days.

This study represents the first clinical application of the ACB device on a robotic surgical platform (Da Vinci) in humans. It is designed as a prospective, multicenter, single-arm, exploratory pilot study (safety and feasibility phase), conducted across four Spanish hepatobiliopancreatic referral centers. All enrolled participants will undergo robotic distal pancreatectomy in which pancreatic transection is performed using the ACB device; there is no concurrent comparator arm, as the study's purpose is to characterize the device's safety and technical performance rather than to test superiority or equivalence against an alternative technique.

The surgical technique will be standardized across participating centers and performed exclusively by surgeons who have completed a defined learning curve with the laparoscopic Coolingbis® device and who have documented prior experience with robotic pancreatic surgery. Intraoperative ultrasound will guide selection of the transection line within healthy proximal parenchyma. Splenic preservation or formal splenopancreatectomy will be selected according to lesion type.

Participants will be followed prospectively through the postoperative hospital course and for 12 months thereafter to characterize both early surgical outcomes and longer-term functional, oncologic, and quality-of-life outcomes. Findings from this pilot cohort are intended to establish a preliminary safety profile for the ACB device, identify clinical or anatomical risk factors associated with RF-assisted robotic transection, and inform patient selection criteria and sample size planning for a subsequent, adequately powered clinical trial supporting future CE certification of the device for robotic use.

Interventions

• Device Internally-cooled bipolar radiofrequency device
  A robotic-compatible, internally-cooled bipolar radiofrequency device (Attachable Coolingbis®, ACB) used to coagulate and transect the pancreatic parenchyma during robotic distal pancreatectomy.

Primary outcome measures

• Incidence of Serious Adverse Events (SAE) [Time frame: from surgery up to 90 days]
• Incidence of Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) [Time frame: From surgery up to 90 days postoperatively]
• Incidence of Post-Pancreatectomy Hemorrhage (PPH) [Time frame: From surgery up to 90 days postoperatively]
• Overall Postoperative Morbidity [Time frame: From the day of surgery up to the day of hospital discharge]
• Postoperative Mortality [Time frame: From the day of surgery up to 90 days postoperatively]

Secondary outcome measures (7)

• Total Surgical Time and Pancreatic Transection Time [Time frame: Intraoperative (during the surgical procedure)]
• Blood Transfusion [Time frame: Intraoperatively]
• Reintervention Rate [Time frame: From surgery up to 90 days postoperatively]
• Hospital Readmission Rate [Time frame: 30 and 90 days after the day of hospital discharge]
• Length of Hospital Stay [Time frame: From the day of surgery to the day of hospital discharge]
• Quality of Recovery (QoR-15 Score) [Time frame: Preoperative and postoperative day 3]
• Post operative blood transfusion [Time frame: From the day 1 of surgery until the discharge fro the hospital]

Eligibility criteria

Inclusion criteria

• Age 18 years or older
• Diagnosis of solid or cystic pancreatic neoplasm (benign, premalignant, or malignant) with surgical indication
• Requirement for distal pancreatectomy with a planned transection line located more than 2 cm to the left of the medial border of the superior mesenteric vein (SMV), confirmed by CT or MRI performed within 2 months prior to surgery
• Eligible for either splenic-preserving distal pancreatectomy or distal splenopancreatectomy
• Eligible for open or minimally invasive surgical approach (laparoscopic or robotic)
• Able to provide written informed consent

Exclusion criteria

• ASA (American Society of Anesthesiologists) physical status classification greater than 3
• Legal or cognitive incapacity to sign informed consent
• Confirmed or ongoing pregnancy
• Need for emergency surgery (e.g., post-traumatic pathology or acute complications)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Sanchez-Velazquez P, Pueyo-Periz E, Alamo JM, Suarez Artacho G, Gomez Bravo MA, Marcello M, Vicente E, Quijano Y, Ferri V, Caruso R, Dorcaratto D, Sabater L, Gonzalez Chavez P, Noguera J, Navarro Gonzalo A, Bellido-Luque J, Tellez-Marques C, Ielpo B, Burdio F. Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised c PMID 36332946
• Pueyo-Periz E, Tellez-Marques C, Radosevic A, Morato O, Visa L, Ilzarbe L, Berjano E, de Vicente E, Poves I, Ielpo B, Grande L, Burdio F, Sanchez-Velazquez P. Radiofrequency-assisted transection of the pancreas vs stapler in distal pancreatectomy: a propensity score matched cohort analysis. Sci Rep. 2022 May 6;12(1):7486. doi: 10.1038/s41598-022-11583-0. PMID 35523857
• Dorcaratto D, Burdio F, Fondevila D, Andaluz A, Poves I, Martinez MA, Quesada R, Berjano E, Grande L. Laparoscopic distal pancreatectomy: feasibility study of radiofrequency-assisted transection in a porcine model. J Laparoendosc Adv Surg Tech A. 2012 Apr;22(3):242-8. doi: 10.1089/lap.2011.0417. Epub 2012 Jan 30. PMID 22288880
• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
• Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005. PMID 17981197
• Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; Int PMID 28040257
• Andaluz A, Ewertowska E, Moll X, Aguilar A, Garcia F, Fondevila D, Quesada R, Berjano E, Grande L, Burdio F. Endoluminal radiofrequency ablation of the main pancreatic duct is a secure and effective method to produce pancreatic atrophy and to achieve stump closure. Sci Rep. 2019 Apr 11;9(1):5928. doi: 10.1038/s41598-019-42411-7. PMID 30976043

Identifiers

NCT: NCT07687901 · CPP2024-011438 · CPP2024-011438

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗