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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy and Institutional Prehabilitation Protocol
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.

Nepal1 site
  • Gonish Hada

    Kathmandu, Bagmati, 00977

Other trials in Nepal

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 groups in NCT07038161
Study groupRoleWhat they receive
Modified Cattell-Warren Technique for PancreaticojejunostomyAll 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.

  1. 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)
  1. 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)

  2. 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.

  3. 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.

  1. First posted26 Jun 2025
  2. Study start1 Apr 2023
  3. Primary completion4 Jun 2025
  4. Study completion9 Jun 2025

Resources

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)
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 37901736
  • Sun 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 27826046
  • Hai 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 35289922
  • Hao 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

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.

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