Clinical trial NCT04151394: Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)
Official title: Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Neoplasm
Gastrointestinal Disease
Surgery--Complications
Survival
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Badajoz
First posted: 2019-11-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who, from January 2010 to December 2018, underwent surgical procedures in our unit for duodenal tumors or other type of primary lesions.

Brief summary: 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

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Complication
timeFrame: 90 days
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Gerardo Blanco-Fernández
Study officials:
References: