PancreatectomyNCT07687901
Attachable Coolingbis® for Distal Pancreatectomy
An observational study of Pancreatectomy, run by Hospital del Mar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy
- What is being tested?
- Internally-cooled bipolar radiofrequency device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Aug 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatectomy
- Being tested
- Internally-cooled bipolar radiofrequency device
- Keywords
- Robot, Distal Pancreatectomy, Radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internally-cooled bipolar radiofrequency deviceDevice
A robotic-compatible, internally-cooled bipolar radiofrequency device (Attachable Coolingbis®, ACB) used to coagulate and transect the pancreatic parenchyma during robotic distal pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Distal Pancreatectomy with Radiofrequency | Participants undergoing robotic distal pancreatectomy in which pancreatic parenchymal transection is performed using the Attachable Coolingbis® radiofrequency device. Receives: Device: Internally-cooled bipolar radiofrequency device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: From the day of surgery up to 90 days postoperatively
Secondary outcomes (7)
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.
Measured: Intraoperative (during the surgical procedure)
Blood Transfusion
Number of unit of red blood cell transfusion during the intraoperative postoperative period
Measured: Intraoperatively
Reintervention Rate
Proportion of participants requiring surgical, radiological, or endoscopic reintervention during the postoperative period.
Measured: From surgery up to 90 days postoperatively
Hospital Readmission Rate
Proportion of participants readmitted to hospital for surgery-related causes within 30 and within 90 days after discharge.
Measured: 30 and 90 days after the day of hospital discharge
Length of Hospital Stay
Total duration of hospitalization, measured in days, from the date of surgery to definitive hospital discharge.
Measured: From the day of surgery to the day of hospital discharge
Quality of Recovery (QoR-15 Score)
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)
Measured: Preoperative and postoperative day 3
Post operative blood transfusion
Number of unit of red blood cell transfusion during the postoperative period until discharge
Measured: From the day 1 of surgery until the discharge fro the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM)
- Responsible party
- Principal investigator, Benedetto Ielpo, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687901
- Sponsor's protocol ID
- CPP2024-011438
- Other IDs
- CPP2024-011438
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 clinical trial (TRANSPAIRE). BMJ Open. 2022 Nov 4;12(11):e062873. doi: 10.1136/bmjopen-2022-062873.
PubMed 36332946Pueyo-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.
PubMed 35523857Dorcaratto 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.
PubMed 22288880Dindo 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.
PubMed 15273542Wente 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.
PubMed 17981197Bassi 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.
PubMed 28040257Andaluz 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.
PubMed 30976043
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Radiofrequency-Assisted Robotic Distal Pancreatectomy (Attachable Coolingbis®)
- ClinicalTrials.gov ID
- NCT07687901
- Acronym / sponsor ID
- CPP2024-011438
- Conditions
- Pancreatectomy
- Keywords
- Robot, Distal Pancreatectomy, Radiofrequency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Distal Pancreatectomy with Radiofrequency | – | Device: Internally-cooled bipolar radiofrequency deviceParticipants undergoing robotic distal pancreatectomy in which pancreatic parenchymal transection is performed using the Attachable Coolingbis® radiofrequency device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internally-cooled bipolar radiofrequency deviceA robotic-compatible, internally-cooled bipolar radiofrequency device (Attachable Coolingbis®, ACB) used to coagulate and transect the pancreatic parenchyma during robotic distal pancreatectomy. | Device | Robotic Distal Pancreatectomy with Radiofrequency |
Primary outcome
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.
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.
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
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
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 36332946Sanchez-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.
- Background: PubMed 35523857Pueyo-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.
- Background: PubMed 22288880Dorcaratto 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 17981197Wente 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.
- Background: PubMed 28040257Bassi 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.
- Background: PubMed 30976043Andaluz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy, run by Hospital del Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedetto Ielpo, MD, PhD (0034 932 48 30 00, ielpo.b@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events (SAE) (time frame: from surgery up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687901, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.