Health TrialsbyHealthPanel

Attachable Coolingbis® for Distal Pancreatectomy

ConditionPancreatectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital del Mar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Robotic Distal Pancreatectomy with Radiofrequency1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
from surgery up to 90 days
2

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.

Time frame
From surgery up to 90 days postoperatively
3

Incidence of Post-Pancreatectomy Hemorrhage (PPH)

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

Time frame
From surgery up to 90 days postoperatively
4

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

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

Secondary outcomes

1

Total Surgical Time and Pancreatic Transection Time

Total duration of the surgical procedure and time specifically required for pancreatic parenchymal transection using the ACB device, both measured in minutes.

Time frame
Intraoperative (during the surgical procedure)
2

Blood Transfusion

Number of unit of red blood cell transfusion during the intraoperative postoperative period

Time frame
Intraoperatively
3

Reintervention Rate

Proportion of participants requiring surgical, radiological, or endoscopic reintervention during the postoperative period.

Time frame
From surgery up to 90 days postoperatively
4

Hospital Readmission Rate

Proportion of participants readmitted to hospital for surgery-related causes within 30 and within 90 days after discharge.

Time frame
30 and 90 days after the day of hospital discharge

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital del Mar

Lead sponsor

Hospital del Mar Research Institute (IMIM)

Collaborator

Source ClinicalTrials.gov

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