Attachable Coolingbis® for Distal Pancreatectomy

June 30, 2026 updated by: Benedetto Ielpo, Hospital del Mar

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Benedetto Ielpo, MD, PhD
  • Phone Number: 0034 932 48 30 00
  • Email: ielpo.b@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Serious Adverse Events (SAE)
Time Frame: from surgery up to 90 days
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)
Time Frame: From surgery up to 90 days postoperatively
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)
Time Frame: From surgery up to 90 days postoperatively
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
Time Frame: From the day of surgery up to the day of hospital discharge
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
Time Frame: From the day of surgery up to 90 days postoperatively
Proportion of participants who die from any cause within 90 days following surgery.
From the day of surgery up to 90 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Surgical Time and Pancreatic Transection Time
Time Frame: Intraoperative (during the surgical procedure)
Total duration of the surgical procedure and time specifically required for pancreatic parenchymal transection using the ACB device, both measured in minutes.
Intraoperative (during the surgical procedure)
Blood Transfusion
Time Frame: Intraoperatively
Number of unit of red blood cell transfusion during the intraoperative postoperative period
Intraoperatively
Reintervention Rate
Time Frame: From surgery up to 90 days postoperatively
Proportion of participants requiring surgical, radiological, or endoscopic reintervention during the postoperative period.
From surgery up to 90 days postoperatively
Hospital Readmission Rate
Time Frame: 30 and 90 days after the day of hospital discharge
Proportion of participants readmitted to hospital for surgery-related causes within 30 and within 90 days after discharge.
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
Total duration of hospitalization, measured in days, from the date of surgery to definitive hospital discharge.
From the day of surgery to the day of hospital discharge
Quality of Recovery (QoR-15 Score)
Time Frame: Preoperative and postoperative day 3
Change in quality of recovery from baseline, assessed using the validated QoR-15 questionnaire, comparing preoperative scores with scores obtained on postoperative day 3. Score: Min 0 (worst quality of life); Max 150 (Best quality of life)
Preoperative and postoperative day 3
Post operative blood transfusion
Time Frame: From the day 1 of surgery until the discharge fro the hospital
Number of unit of red blood cell transfusion during the postoperative period until discharge
From the day 1 of surgery until the discharge fro the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Collaborators

Hospital del Mar Research Institute (IMIM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPP2024-011438 (Other Grant/Funding Number: Agenda Estatal de Investigación)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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