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Completed

NCT Number: NCT04151394

Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)

Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis.

The investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy

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Key information

About this study

The investigators retrospectively looked at patients who, from January 2010 to December 2018, underwent surgical procedures for duodenal tumors or other type of primary lesions.

Patients with primary duodenal lesions who underwent surgery were included in the study. Patients with secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration were excluded. Similarly, if the surgeons appreciate the involvement of the pancreas during the procedure, for which they would have to perform a pancreaticoduodenectomy, the patient would be excluded.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including endoscopic exploration and, when neoplasm was suspected, computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for reconstruction according to the location.

The variables taken into account were age, sex, the American Society of Anesthesiologists (ASA) classification, preoperative examinations performed and type of lesion susppected as benign, duodenal adenocarcinoma or gastrointestinal stromal tumor (GIST). Perioperative clinical results, surgical approach, type of resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (< 90 days after operation). Some of the key long-term data recorded were, digestive symptoms along follow-up, specific disease-free survival (DFS) and overall survival (OS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary duodenal lesions who underwent surgery

Exclusion criteria

  • Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration

Treatment and study plan

Duodenojejunostomy

Procedure

Resection of duodenal lesions and reconstruction by duodenojejunostomy

Primary outcomes

  1. Complication

    Time frame: 90 days

    Surgical complications rates

  2. Overall survival

    Time frame: 10 years

    Patients overall survival after resection

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Collaborators

  • Complejo Hospitalario Universitario de Badajoz

Registry information

Official study title

Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation

Acronym: DUORESECT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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