The Novel Modified Cattell-Warren Duct-To-Mucosa Pancreaticojejunostomy Technique Significantly Reduces POPF.

NCT07038161 | Completed

• 1 other identifier: 45-081/082
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Pancreaticoduodenectomy; Distal Pancreatectomy; Postoperative Pancreatic Fistula

Keywords

Duct-to-mucosa; pancreaticojejunostomy; Postoperative pancreatic fistula; Modified Cattell-Warren technique

Outcome Measures

Primary Outcomes (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.

  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

  up to 90 postoperative days and during follow-up in OPD (as per departmental protocol for this study)

• Length of hospital stay

  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

  up to 30 postoperative days or till the date of in-hospital mortality due to any cause, assessed upto 30 postoperative days

Study Arms (1)

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.

Procedure: Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy; Behavioral: Institutional Prehabilitation Protocol

Interventions

Modified Cattell-Warren duct-to-mucosa pancreaticojejunostomy PROCEDURE

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.

Modified Cattell-Warren Technique for Pancreaticojejunostomy

Institutional Prehabilitation Protocol BEHAVIORAL

Routine perioperative incentive spirometry, four extremities exercise, and nutritional optimization with albumin and Total Parenteral Nutrition

Modified Cattell-Warren Technique for Pancreaticojejunostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nepal Medical College and Teaching Hospital: lead

Study Sites (1)

Gonish Hada

Kathmandu, Bagmati, 00977, Nepal

Location

Related Publications (4)

• 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.

  PMID: 37901736 BACKGROUND

• 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.

  PMID: 27826046 BACKGROUND

• 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.

  PMID: 35289922 BACKGROUND

• 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.

  PMID: 39040391 BACKGROUND

Study Officials

• Nabin Pokharel, MBBBS,MS,MCh

  Nepal Medical College and Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Official Title: Prof Dr. Nabin Pokharel, Head of Department of Surgical Gastroenterology Affiliation: Nepal Medical College and Teaching Hospital

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 26, 2025
• Study Start: April 1, 2023
• Primary Completion: June 4, 2025
• Study Completion: June 9, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)