Clinical Trials Directory

Trials / Completed

CompletedNCT06863389

Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy

Status
Completed
Phase
Study type
Observational
Enrollment
5,788 (actual)
Sponsor
Chen Xiaoping · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.

Conditions

Interventions

TypeNameDescription
PROCEDUREChen's U-suture techniqueInitially, an approximately 2 cm cut edge of the pancreas remnant was mobilized and a incision of the jejunal loop was conducted slightly shorter than the pancreatic remnant. Using dual-needle 3-0 prolene suture for anastomosis, needle A went through the entire intestinal wall from the posterior wall about 1.5 cm away from the resection margin of the jejunum loop, then went through the superior boarder of the pancreas from posterior to anterior. To suture the anterior wall of the jejunum loop, the stitch next entered from the resection margin of the jejunum loop and kept it within the seromuscular layer from proximal to distal, and got out from about 1.5 cm away from the resection margin. Needle B repeated the aforementioned procedures with a parallel distance about 1.0 cm between needle A. Generally, the whole anastomosis needed two to four identical stitches. The stitches should overlap each other to reduce pancreatic leakage. Once all the stitches were finished and tighte
PROCEDUREinvaginationFirstly, using 3-0 silk sutures, the pancreatic capsule and the serosa of the jejunal loop were anastomosed interruptedly to constitute the posterior outer layer of the anastomosis. Secondly, a jejunotomy with an appropriate size was performed and the inner layer (including posterior and anterior) of invagination was formed by two 5-0 prolene sutures with a continuous running between the pancreatic parenchyma and the full-thickness jejunum. Thirdly, the anterior outer layer was sutured in line with the first step.
PROCEDUREDuct-to-MucosaBriefly, Duct-to-Mucosa should make a opening matched to the pancreatic duct and was also performed by two layers. One was the outer layer in both the anterior and posterior walls of the anastomosis which were formed by interrupted 3-0 silk sutures betweent the pancreatic capsule and the jejunal serosa. The other was the inner layer performed in eight to twelve stitches from pancreatic duct to jejunal mucosa with 5-0 prolene sutures.

Timeline

Start date
2014-01-01
Primary completion
2019-12-01
Completion
2024-06-01
First posted
2025-03-07
Last updated
2025-03-07

Source: ClinicalTrials.gov record NCT06863389. Inclusion in this directory is not an endorsement.