Attachable Coolingbis® for Distal Pancreatectomy

NCT07687901 | Not Yet Recruiting DMC

• 1 other identifier: CPP2024-011438
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatectomy

Keywords

Robot; Distal Pancreatectomy; Radiofrequency

Outcome Measures

Primary Outcomes (5)

• Incidence of Serious Adverse Events (SAE)

  Number and proportion of participants experiencing at least one serious adverse event (SAE) during the study period, regardless of causal relationship to the Attachable Coolingbis® device or the robotic surgical procedure. Each event will be assessed by the investigator for severity and classified by causality as possibly related, not related/unlikely, or ambiguous (with ambiguous cases conservatively classified as possibly related). SAEs will be recorded and reported in accordance with Good Clinical Practice and applicable medical device vigilance requirements.

  from surgery up to 90 days

• Incidence of Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)

  Proportion of participants developing clinically relevant postoperative pancreatic fistula, defined as Grade B or C according to the updated International Study Group of Pancreatic Surgery (ISGPS) criteria . CR-POPF will be determined by drain fluid amylase concentration greater than 3 times the upper limit of normal serum amylase, measured systematically on postoperative days 3 and 5 (or until drain removal), combined with an associated clinically relevant condition altering postoperative management.

  From surgery up to 90 days postoperatively

• Incidence of Post-Pancreatectomy Hemorrhage (PPH)

  Proportion of participants experiencing postoperative hemorrhage, classified by grade (A, B, or C) according to ISGPS criteria

  From surgery up to 90 days postoperatively

• Overall Postoperative Morbidity

  Incidence and severity of any postoperative complication occurring between surgery and hospital discharge, graded according to the Clavien-Dindo classification. Cumulative postoperative morbidity will additionally be summarized using the Comprehensive Complication Index (CCI), a continuous scale from 0 to 100

  From the day of surgery up to the day of hospital discharge

• Postoperative Mortality

  Proportion of participants who die from any cause within 90 days following surgery.

  From the day of surgery up to 90 days postoperatively

Secondary Outcomes (7)

• Total Surgical Time and Pancreatic Transection Time

  Intraoperative (during the surgical procedure)

• Blood Transfusion

  Intraoperatively

• Reintervention Rate

  From surgery up to 90 days postoperatively

• Hospital Readmission Rate

  30 and 90 days after the day of hospital discharge

• Length of Hospital Stay

  From the day of surgery to the day of hospital discharge

Study Arms (1)

Robotic Distal Pancreatectomy with Radiofrequency

Participants undergoing robotic distal pancreatectomy in which pancreatic parenchymal transection is performed using the Attachable Coolingbis® radiofrequency device.

Device: Internally-cooled bipolar radiofrequency device

Interventions

Internally-cooled bipolar radiofrequency device DEVICE

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

Robotic Distal Pancreatectomy with Radiofrequency

Eligibility Criteria

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

Study Population

Consecutive cohort of adult patients with a clinical indication for distal pancreatectomy due to solid or cystic pancreatic neoplasms (benign, premalignant, or malignant), recruited from the surgical waiting lists of four Spanish hepatobiliopancreatic referral centers (Hospital del Mar, Barcelona; Hospital Universitario HM Sanchinarro, Madrid; Hospital Clínico Universitario de Valencia; Hospital Universitario Virgen del Rocío, Sevilla). Approximately 5 patients per center are expected to be enrolled, based on each center's estimated annual surgical volume for this indication (5-7 cases/year). All participants will be drawn from patients who are surgical candidates for robotic distal pancreatectomy and who meet the anatomical requirement of a planned transection line located more than 2 cm to the left of the medial border of the superior mesenteric vein.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital del Mar: lead
• Hospital del Mar Research Institute (IMIM): collaborator

Related Publications (7)

• 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 clinical trial (TRANSPAIRE). BMJ Open. 2022 Nov 4;12(11):e062873. doi: 10.1136/bmjopen-2022-062873.

  PMID: 36332946 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

  PMID: 28040257 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Benedetto Ielpo, MD, PhD

CONTACT

0034 932 48 30 00; ielpo.b@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical Unit, Associate Professor of Pompeu Fabra University , Principal Investigator

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share