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Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection

Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03597230
Enrollment
20
Registered
2018-07-24
Start date
2018-10-22
Completion date
2020-10-22
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Resection

Brief summary

Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%. No precise anatomic pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes. The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

Detailed description

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The prognosis and life expectancy for people with pancreatic cancer remain very low (3rd cause of mortality among all cancer). Surgical resection is the only curative treatment, whenever possible. Nevertheless, major pancreatectomies lead to high postoperative morbidity rate, in particular up to 30% fistula rate. In case of parenchyma-sparing procedures, this rate is even higher, up to 40%. One of the reasons of these high rates might be explained by the fact that pancreatic transections are currently not performed following pancreatic segmentation. If possible, resection following vascular segmentation would prevent necrosis of the transection, resection following lymphatic segmentation would improve the lymph-node dissection, and resection following pancreatic-duct segmentation would prevent leakage from pancreatic duct stump. Nevertheless, no precise anatomic pancreatic segmentation currently exists. On the other hand, the lymphatic system of the pancreas is highly complex, but the quality of the lymphadenectomy during pancreatectomy is essential since the recurrences almost always occur on the lymphatic transections. A better knowledge of the peri-pancreatic lymphatic vessels is still required. The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

Interventions

OTHERDye

Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patient operated on for pancreatic resection * Patients consenting the protocol after clear and loyal explanations

Exclusion criteria

* history of first abdominal surgery in the upper part * Patients with peritoneal carcinomatosis

Design outcomes

Primary

MeasureTime frameDescription
Lymph node areas colored by the diffusion of the blue patent3 minutes after the injectionAt the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.

Countries

France

Contacts

Primary ContactYohann RENARD
yrenard@chu-reims.fr3 26 78 71 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026