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| ID | Type | Description | Link |
|---|---|---|---|
| KI-DSGE-DUAS | Other Identifier | Karolinska Institutet |
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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
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Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional anastomosis | No Intervention | Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique". | |
| Novel anastomosis | Active Comparator | Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticojejunostomy technique | Procedure | The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Relevant Postoperative Pancreatic Fistula | Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Associated postoperative morbidity | Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of postoperative complications | The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Ansorge, MD, PhD | Karolinska Institutet | Principal Investigator |
| Ralf Segersvärd, MD, PhD | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Upper Abdominal Surgery, Linköping University Hospital | Linköping | 58185 | Sweden | |||
| Department of Surgical gastroenterology, Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16003309 | Background | Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001. | |
| 22556164 |
| Label | URL |
|---|---|
| Issuer organization | View source |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D010193 | Pancreaticojejunostomy |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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| Stockholm |
| 14186 |
| Sweden |
| Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4. |
| 21845376 | Background | Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y. |
| Investigation site | View source |
| Investigation site | View source |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |