PancreaticoduodenectomyPOPFNCT07038161
The Novel Modified Cattell-Warren Duct-To-Mucosa Pancreaticojejunostomy Technique Significantly Reduces POPF.
An observational study of Pancreaticoduodenectomy and Distal Pancreatectomy, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
Trial summary
Pancreatic surgeries, such as pancreaticoduodenectomy and distal pancreatectomy, are associated with high morbidity and mortality. The most common cause of this morbidity is postoperative pancreatic fistula(POPF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy, Distal Pancreatectomy, Postoperative Pancreatic Fistula
- What is being tested?
- Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy and Institutional Prehabilitation Protocol
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2023to 9 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients undergoing the modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy technique in the pancreaticoduodenectomy or distal pancreatectomy in the department of Surgical Gastroenterology in the Nepal Medical College and Teaching Hospital.
Who may be able to join
- Patient undergoing duct to mucosa PJ (the modified Cattell Warren technique) in pancreatic surgery for presumed or diagnosed malignancy of the head of the pancreas and periampullary carcinoma.
- Patient undergoing distal pancreatectomy for presumed or diagnosed malignancy or cystic neoplasm of the pancreas involving the body and tail.
- Age > 18 years
Who cannot join
- Other techniques of reconstruction like Dunking, Blumgart's, and binding technique.
- Patient with previous pancreatic resection for any etiology
- Patient undergoing extended pancreaticoduodenectomy
- Arterial resection or divestment
- Multi-visceral resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duct To Mucosa Pancreaticojejunostomy (The Novel Modified Cattell Warren Technique) Significantly Reduces POPF: A Single-Center Experience
Pancreatic surgeries, such as pancreaticoduodenectomy and distal pancreatectomy, are associated with high morbidity and mortality. The most common cause of this morbidity is postoperative pancreatic fistula(POPF). The risk of POPF depends on the texture of pancreatic parenchyma, the size of the main pancreatic duct, and the technique of pancreatic-enteric reconstruction. There are several techniques for pancreaticojejunostomy anastomosis. Among which duct to mucosa is considered a relatively safe anastomosis technique. However, there are several modifications to the duct-to-mucosa technique. The investigators of this study believe that the modified Cattell-Warren duct-to-mucosa technique, which includes taking more than 5 mm of periductal pancreatic parenchyma with the duct and the full-thickness jejunum while performing pancreaticojejunostomy reconstruction with proper perioperative nutritional optimization and prehabilitation, improves patient outcomes. So the investigators aim to assess the risk of POPF in the novel modified Cattell-Warren technique.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive malignancies. The incidence of pancreatic cancer is rising, with over 500,000 new cases worldwide, especially with increasing trends in developing countries. It is associated with high morbidity and mortality due to its aggressive nature and late diagnosis of the disease. Only 15-20% of the disease is resectable at presentation, and another 30% of patients have a borderline resectable disease. Pancreaticoduodenectomy (PD) is the only treatment with curative intent for pancreatic head tumors and periampullary tumors. Though the mortality associated with PD has decreased with the experience of surgeons, the morbidity still hovers around 30-50%. Adjuvant chemotherapy is crucial in improving survival outcomes, with median survival reaching 24-30 months. However, a significant subset of patients undergoing PD is unable to undergo or tolerate adjuvant chemotherapy due to its high surgical morbidity, prolonged recovery, or poor performance status. Around 30-40% of patients do not receive adjuvant therapy as planned due to surgical morbidity, which negatively impacts long-term survival.
Pancreatic surgery, including PD and distal pancreatectomy (DP) is a highly complex surgery requiring multiple reconstructive anastomoses with significant risk of postoperative morbidity, even in a high-volume center. Pancreaticojejunostomy (PJ) is the most technically demanding reconstructive anastomosis due to its high risk of anastomotic leaks, resulting in postoperative morbidity. The most common cause of this morbidity is due to Postoperative pancreatic fistula (POPF), while other causes include Post-pancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE), biliary and enteric leaks, pancreatic endocrine and exocrine insufficiency, and wound-related complications. POPF is the most feared and dreadful complication following pancreatic surgery for both benign and malignant pathology. The pancreatic parenchymal texture, duct diameter, and technique of anastomosis of the pancreatic-enteric reconstruction are important factors that influence the formation of POPF. Duct-to-mucosa and its modification, Invagination (Dunking), Binding, or Pancreaticogastrostomy (PG) are techniques for the reconstruction of the pancreatic remnant. The Catell-Warren technique, described in 1956, is the duct to mucosa PJ technique, which is a widely used technique that ensures a secure anastomosis of the pancreatic duct with jejunal mucosa. It is considered to be one of the most precise PJ techniques, which is found to reduce POPF significantly. The secure 2-layer anastomosis, minimization of parenchymal trauma, proper ductal drainage, better healing, and lower risk of anastomotic strictures make this technique an optimal PJ technique. The duct to mucosa PJ technique is the preferred technique when the MPD diameter is > 3mm. However, this technique is being safely done even with an MPD diameter of >1mm without a significant increase in POPF risk. Among various PJ techniques, the duct-to-mucosa technique is widely used because of its precise and direct alignment between the pancreatic remnant and jejunal mucosa, theoretically minimizing the risk of POPF.
However, modification in surgical technique, variation in use of internal or external stents, use of perioperative octreotide, patient-specific factors, and institutional surgical protocol create inconsistent results in clinical practice. Despite the advantages of the duct-to-mucosa PJ technique, the clinical efficacy and safety of this technique remain debated, with some studies suggesting no clear superiority over other methods. Given the ongoing debate and variability in outcomes, there is a need for focused evaluation of the duct-to-mucosa PJ to quantify its impact on the incidence and severity of POPF, technical feasibility, and safety of the technique, and to standardize the anastomotic technique in pancreatic surgery.
Demographic data, investigation parameters, intraoperative findings, and surgical outcomes will be retrieved from the departmental database. Statistical tests for comparison will be done using SPSS version 16.0. Continuous variables will be presented as Mean + Standard Deviation (SD), and categorical variables will be presented as Number (percentage). Analysis will be done using the chi-square test and student t-test wherever applicable, and other statistical tests as per requirement. The level of significance will be set at 5%, and p p-value <0.05 will be considered statistically significant.
- Being tested
- Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy, Institutional Prehabilitation Protocol
- Keywords
- Duct-to-mucosa, pancreaticojejunostomy, Postoperative pancreatic fistula, Modified Cattell-Warren technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomyProcedure or surgery
Technical modification of the original Cattell-Warren technique in all the stitches of both posterior and anterior duct-to-mucosa layer, taking the pancreatic duct with more than 5mm of pancreatic parenchyma adjacent to the duct and towards the jejunal side, taking more than 5 mm of full-thickness jejunum including mucosa.
Institutional Prehabilitation ProtocolBehavioural
Routine perioperative incentive spirometry, four extremities exercise, and nutritional optimization with albumin and Total Parenteral Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Modified Cattell-Warren Technique for Pancreaticojejunostomy | All patients undergoing the duct-to-mucosa (the Modified Cattell-Warren technique) for pancreaticojejunostomy in the Pancreaticoduodenectomy and Distal Pancreatectomy. Receives: Procedure: Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy; Behavioral: Institutional Prehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically relevant postoperative pancreatic fistula
To assess the rate of clinically relevant postoperative pancreatic fistula (CR POPF) in the standard time frame as per ISGPS guidelines.
Measured: Assessed between postoperative day 3 and up to 30 days
Secondary outcomes (3)
Number of patients with other postoperative complications based on the Clavien-Dindo Classification grading
Number of patients with other postoperative complications based on the Clavien-Dindo Classification grading in the standard time frame as per ISGPS guidelines
Measured: up to 90 postoperative days and during follow-up in OPD (as per departmental protocol for this study)
Length of hospital stay
The association between complication severity and LOS was evaluated by comparing LOS across Clavien-Dindo grades. Prolonged LOS was defined as hospitalization >75th percentile of the cohort.
Measured: Length of hospital stay (LOS) was defined as the time (in days) from the date of surgery to the date of hospital discharge, assessed up to 90 days postoperatively.
Mortality
Number of patients with in-hospital postoperative mortality
Measured: up to 30 postoperative days or till the date of in-hospital mortality due to any cause, assessed upto 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Apr 2023
- Primary completion4 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepal Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabin Pokharel, Nepal Medical College and Teaching Hospital
- Investigators
- Nabin Pokharel, MBBBS,MS,MCh, Principal investigator, Nepal Medical College and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038161
- Sponsor's protocol ID
- 45-081/082
- Acronym
- POPF
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Yu XF, Yao H, Xu S, Ma YQ, Chai C. Safety and feasibility of modified duct-to-mucosa pancreaticojejunostomy during pancreatoduodenectomy: A retrospective cohort study. World J Gastrointest Surg. 2023 Sep 27;15(9):1901-1909. doi: 10.4240/wjgs.v15.i9.1901.
PubMed 37901736Sun X, Zhang Q, Zhang J, Lou Y, Fu Q, Zhang X, Liang T, Bai X. Meta-analysis of invagination and duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: An update. Int J Surg. 2016 Dec;36(Pt A):240-247. doi: 10.1016/j.ijsu.2016.11.008. Epub 2016 Nov 5.
PubMed 27826046Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.
PubMed 35289922Hao X, Li Y, Liu L, Bai J, Liu J, Jiang C, Zheng L. Is duct-to-mucosa pancreaticojejunostomy necessary after pancreaticoduodenectomy: A meta-analysis of randomized controlled trials. Heliyon. 2024 Jun 15;10(13):e33156. doi: 10.1016/j.heliyon.2024.e33156. eCollection 2024 Jul 15.
PubMed 39040391
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duct To Mucosa Pancreaticojejunostomy (The Novel Modified Cattell Warren Technique) Significantly Reduces POPF: A Single-Center Experience
- ClinicalTrials.gov ID
- NCT07038161
- Acronym / sponsor ID
- POPF / 45-081/082
- Keywords
- Duct-to-mucosa, pancreaticojejunostomy, Postoperative pancreatic fistula, Modified Cattell-Warren technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nepal Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 26 Jun 2025 (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.
Pancreatic surgeries, such as pancreaticoduodenectomy and distal pancreatectomy, are associated with high morbidity and mortality. The most common cause of this morbidity is postoperative pancreatic fistula(POPF). The risk of POPF depends on the texture of pancreatic parenchyma, the size of the main pancreatic duct, and the technique of pancreatic-enteric reconstruction. There are several techniques for pancreaticojejunostomy anastomosis. Among which duct to mucosa is considered a relatively safe anastomosis technique. However, there are several modifications to the duct-to-mucosa technique. The investigators of this study believe that the modified Cattell-Warren duct-to-mucosa technique, which includes taking more than 5 mm of periductal pancreatic parenchyma with the duct and the full-thickness jejunum while performing pancreaticojejunostomy reconstruction with proper perioperative nutritional optimization and prehabilitation, improves patient outcomes. So the investigators aim to assess the risk of POPF in the novel modified Cattell-Warren technique.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive malignancies. The incidence of pancreatic cancer is rising, with over 500,000 new cases worldwide, especially with increasing trends in developing countries. It is associated with high morbidity and mortality due to its aggressive nature and late diagnosis of the disease. Only 15-20% of the disease is resectable at presentation, and another 30% of patients have a borderline resectable disease. Pancreaticoduodenectomy (PD) is the only treatment with curative intent for pancreatic head tumors and periampullary tumors. Though the mortality associated with PD has decreased with the experience of surgeons, the morbidity still hovers around 30-50%. Adjuvant chemotherapy is crucial in improving survival outcomes, with median survival reaching 24-30 months. However, a significant subset of patients undergoing PD is unable to undergo or tolerate adjuvant chemotherapy due to its high surgical morbidity, prolonged recovery, or poor performance status. Around 30-40% of patients do not receive adjuvant therapy as planned due to surgical morbidity, which negatively impacts long-term survival.
Pancreatic surgery, including PD and distal pancreatectomy (DP) is a highly complex surgery requiring multiple reconstructive anastomoses with significant risk of postoperative morbidity, even in a high-volume center. Pancreaticojejunostomy (PJ) is the most technically demanding reconstructive anastomosis due to its high risk of anastomotic leaks, resulting in postoperative morbidity. The most common cause of this morbidity is due to Postoperative pancreatic fistula (POPF), while other causes include Post-pancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE), biliary and enteric leaks, pancreatic endocrine and exocrine insufficiency, and wound-related complications. POPF is the most feared and dreadful complication following pancreatic surgery for both benign and malignant pathology. The pancreatic parenchymal texture, duct diameter, and technique of anastomosis of the pancreatic-enteric reconstruction are important factors that influence the formation of POPF. Duct-to-mucosa and its modification, Invagination (Dunking), Binding, or Pancreaticogastrostomy (PG) are techniques for the reconstruction of the pancreatic remnant. The Catell-Warren technique, described in 1956, is the duct to mucosa PJ technique, which is a widely used technique that ensures a secure anastomosis of the pancreatic duct with jejunal mucosa. It is considered to be one of the most precise PJ techniques, which is found to reduce POPF significantly. The secure 2-layer anastomosis, minimization of parenchymal trauma, proper ductal drainage, better healing, and lower risk of anastomotic strictures make this technique an optimal PJ technique. The duct to mucosa PJ technique is the preferred technique when the MPD diameter is > 3mm. However, this technique is being safely done even with an MPD diameter of >1mm without a significant increase in POPF risk. Among various PJ techniques, the duct-to-mucosa technique is widely used because of its precise and direct alignment between the pancreatic remnant and jejunal mucosa, theoretically minimizing the risk of POPF.
However, modification in surgical technique, variation in use of internal or external stents, use of perioperative octreotide, patient-specific factors, and institutional surgical protocol create inconsistent results in clinical practice. Despite the advantages of the duct-to-mucosa PJ technique, the clinical efficacy and safety of this technique remain debated, with some studies suggesting no clear superiority over other methods. Given the ongoing debate and variability in outcomes, there is a need for focused evaluation of the duct-to-mucosa PJ to quantify its impact on the incidence and severity of POPF, technical feasibility, and safety of the technique, and to standardize the anastomotic technique in pancreatic surgery.
Demographic data, investigation parameters, intraoperative findings, and surgical outcomes will be retrieved from the departmental database. Statistical tests for comparison will be done using SPSS version 16.0. Continuous variables will be presented as Mean + Standard Deviation (SD), and categorical variables will be presented as Number (percentage). Analysis will be done using the chi-square test and student t-test wherever applicable, and other statistical tests as per requirement. The level of significance will be set at 5%, and p p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Cattell-Warren Technique for Pancreaticojejunostomy | – | Procedure: Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy, Behavioral: Institutional Prehabilitation ProtocolAll patients undergoing the duct-to-mucosa (the Modified Cattell-Warren technique) for pancreaticojejunostomy in the Pancreaticoduodenectomy and Distal Pancreatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing the modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy technique in the pancreaticoduodenectomy or distal pancreatectomy in the department of Surgical Gastroenterology in the Nepal Medical College and Teaching Hospital.
Key inclusion criteria (3 listed)
- Patient undergoing duct to mucosa PJ (the modified Cattell Warren technique) in pancreatic surgery for presumed or diagnosed malignancy of the head of the pancreas and periampullary carcinoma.
- Patient undergoing distal pancreatectomy for presumed or diagnosed malignancy or cystic neoplasm of the pancreas involving the body and tail.
- Age > 18 years
Key exclusion criteria (5 listed)
- Other techniques of reconstruction like Dunking, Blumgart's, and binding technique.
- Patient with previous pancreatic resection for any etiology
- Patient undergoing extended pancreaticoduodenectomy
- Arterial resection or divestment
- Multi-visceral resection
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 |
|---|---|---|
| Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomyTechnical modification of the original Cattell-Warren technique in all the stitches of both posterior and anterior duct-to-mucosa layer, taking the pancreatic duct with more than 5mm of pancreatic parenchyma adjacent to the duct and towards the jejunal side, taking more than 5 mm of full-thickness jejunum including mucosa. | Procedure or surgery | Modified Cattell-Warren Technique for Pancreaticojejunostomy |
| Institutional Prehabilitation ProtocolRoutine perioperative incentive spirometry, four extremities exercise, and nutritional optimization with albumin and Total Parenteral Nutrition | Behavioural | Modified Cattell-Warren Technique for Pancreaticojejunostomy |
Primary outcome
Number of patients with clinically relevant postoperative pancreatic fistula
Time frame: Assessed between postoperative day 3 and up to 30 days
To assess the rate of clinically relevant postoperative pancreatic fistula (CR POPF) in the standard time frame as per ISGPS guidelines.
3 secondary outcomes
Number of patients with other postoperative complications based on the Clavien-Dindo Classification grading
Time frame: up to 90 postoperative days and during follow-up in OPD (as per departmental protocol for this study)
Length of hospital stay
Time frame: Length of hospital stay (LOS) was defined as the time (in days) from the date of surgery to the date of hospital discharge, assessed up to 90 days postoperatively.
Mortality
Time frame: up to 30 postoperative days or till the date of in-hospital mortality due to any cause, assessed upto 30 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 37901736Sun Y, Yu XF, Yao H, Xu S, Ma YQ, Chai C. Safety and feasibility of modified duct-to-mucosa pancreaticojejunostomy during pancreatoduodenectomy: A retrospective cohort study. World J Gastrointest Surg. 2023 Sep 27;15(9):1901-1909. doi: 10.4240/wjgs.v15.i9.1901.
- Results publication: PubMed 27826046Sun X, Zhang Q, Zhang J, Lou Y, Fu Q, Zhang X, Liang T, Bai X. Meta-analysis of invagination and duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: An update. Int J Surg. 2016 Dec;36(Pt A):240-247. doi: 10.1016/j.ijsu.2016.11.008. Epub 2016 Nov 5.
- Results publication: PubMed 35289922Hai H, Li Z, Zhang Z, Cheng Y, Liu Z, Gong J, Deng Y. Duct-to-mucosa versus other types of pancreaticojejunostomy for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD013462. doi: 10.1002/14651858.CD013462.pub2.
- Results publication: PubMed 39040391Hao X, Li Y, Liu L, Bai J, Liu J, Jiang C, Zheng L. Is duct-to-mucosa pancreaticojejunostomy necessary after pancreaticoduodenectomy: A meta-analysis of randomized controlled trials. Heliyon. 2024 Jun 15;10(13):e33156. doi: 10.1016/j.heliyon.2024.e33156. eCollection 2024 Jul 15.
- Individual participant dataSharing planned: No
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Patients Who Undergo Pancreaticoduodenectomy
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. This study is not recruiting at the moment.
Nabin Pokharel, MBBBS,MS,MCh principal investigator
Nepal Medical College and Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy and Distal Pancreatectomy, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with clinically relevant postoperative pancreatic fistula (time frame: Assessed between postoperative day 3 and up to 30 days). 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 NCT07038161, which also lists 4 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 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.